Trial Outcomes & Findings for Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD) (NCT NCT01111565)
NCT ID: NCT01111565
Last Updated: 2021-12-21
Results Overview
The MADRS assessed severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms). Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. Last observation carried forward (LOCF) method was used for analyses.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
137 participants
Primary outcome timeframe
Week 8 to Week 14
Results posted on
2021-12-21
Participant Flow
Participants took part in the study at 70 investigative sites in the United States, Canada, France, India, Malaysia, Poland, and South Africa from 4 October 2010 to 1 September 2011.
A total of 137 participants were enrolled in Phase B (Single-blind Prospective Treatment Phase) to receive escitalopram monotherapy(10 or 20mg/day),of which 26 responders continued to Phase B+(Single-blind Phase B Responders),received escitalopram monotherapy(10 or 20mg/day).45 non-responders were randomized in 1:1:1 ratio to Phase C(Double-blind Randomization Phase),received aripiprazole/escitalopram combination therapy or escitalopram or aripiprazole monotherapy.
Participant milestones
| Measure |
Phase B: Single-blind Prospective Treatment Phase
Escitalopram 10 mg capsule, orally, once daily increased to 20 mg/day at the Week 1 (end of Week 1) based upon tolerability profile, for 8 weeks. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the end of the Phase B (Week 8) entered Phase C and the rest of the participants continued to Phase B+.
|
Phase B+: Single-blind Phase B Responders
Participants with response (≥50% reduction in depressive symptom severity in HAM-D17 Total Score; or a HAM-D17 Total Score of \<14 at Week 8 or a Clinical Global Impression of Improvement (CGI-I) Score of \<3 at the Week 6 or 8) at the end of the Phase B (Week 8) continued treatment with the single-blind escitalopram monotherapy at the dose (10 or 20 mg/day) taken during the final week of Phase B, for an additional 6 weeks (Up to Week 14), in Phase B+.
|
Phase C: Aripiprazole/Escitalopram Combination
Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily in combination with the escitalopram 10 or 20 mg orally for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram during Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated.
|
Phase C: Escitalopram Monotherapy
Participants with incomplete response at Week 8 who were randomized to this arm group received escitalopram monotherapy 10 or 20 mg capsule, orally, once daily, whichever dose was taken during the final week of Phase B for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
|
Phase C: Aripiprazole Monotherapy
Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily for 6 weeks (Up to Week 14), in Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated. No dose increments were allowed after Week 12; however, doses may have been decreased at any visit, based upon tolerability.
|
|---|---|---|---|---|---|
|
Phase B (Weeks 0 to 8)
STARTED
|
137
|
0
|
0
|
0
|
0
|
|
Phase B (Weeks 0 to 8)
COMPLETED
|
71
|
0
|
0
|
0
|
0
|
|
Phase B (Weeks 0 to 8)
NOT COMPLETED
|
66
|
0
|
0
|
0
|
0
|
|
Phase B + and Phase C (Weeks 9 to 14)
STARTED
|
0
|
26
|
16
|
14
|
15
|
|
Phase B + and Phase C (Weeks 9 to 14)
COMPLETED
|
0
|
19
|
11
|
10
|
11
|
|
Phase B + and Phase C (Weeks 9 to 14)
NOT COMPLETED
|
0
|
7
|
5
|
4
|
4
|
Reasons for withdrawal
| Measure |
Phase B: Single-blind Prospective Treatment Phase
Escitalopram 10 mg capsule, orally, once daily increased to 20 mg/day at the Week 1 (end of Week 1) based upon tolerability profile, for 8 weeks. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the end of the Phase B (Week 8) entered Phase C and the rest of the participants continued to Phase B+.
|
Phase B+: Single-blind Phase B Responders
Participants with response (≥50% reduction in depressive symptom severity in HAM-D17 Total Score; or a HAM-D17 Total Score of \<14 at Week 8 or a Clinical Global Impression of Improvement (CGI-I) Score of \<3 at the Week 6 or 8) at the end of the Phase B (Week 8) continued treatment with the single-blind escitalopram monotherapy at the dose (10 or 20 mg/day) taken during the final week of Phase B, for an additional 6 weeks (Up to Week 14), in Phase B+.
|
Phase C: Aripiprazole/Escitalopram Combination
Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily in combination with the escitalopram 10 or 20 mg orally for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram during Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated.
|
Phase C: Escitalopram Monotherapy
Participants with incomplete response at Week 8 who were randomized to this arm group received escitalopram monotherapy 10 or 20 mg capsule, orally, once daily, whichever dose was taken during the final week of Phase B for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
|
Phase C: Aripiprazole Monotherapy
Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily for 6 weeks (Up to Week 14), in Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated. No dose increments were allowed after Week 12; however, doses may have been decreased at any visit, based upon tolerability.
|
|---|---|---|---|---|---|
|
Phase B (Weeks 0 to 8)
Lost to Follow-up
|
3
|
0
|
0
|
0
|
0
|
|
Phase B (Weeks 0 to 8)
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
|
Phase B (Weeks 0 to 8)
Sponsor Discontinued Study
|
58
|
0
|
0
|
0
|
0
|
|
Phase B (Weeks 0 to 8)
Investigator Withdrew Subject
|
1
|
0
|
0
|
0
|
0
|
|
Phase B (Weeks 0 to 8)
Subject Withdrew Consent
|
1
|
0
|
0
|
0
|
0
|
|
Phase B (Weeks 0 to 8)
Protocol Deviation
|
1
|
0
|
0
|
0
|
0
|
|
Phase B (Weeks 0 to 8)
Lack of Efficacy as Determined by the Investigator
|
1
|
0
|
0
|
0
|
0
|
|
Phase B + and Phase C (Weeks 9 to 14)
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
|
Phase B + and Phase C (Weeks 9 to 14)
Adverse Event
|
0
|
0
|
2
|
0
|
0
|
|
Phase B + and Phase C (Weeks 9 to 14)
Sponsor Discontinued Study
|
0
|
7
|
3
|
2
|
3
|
|
Phase B + and Phase C (Weeks 9 to 14)
Investigator Withdrew Subjects
|
0
|
0
|
0
|
1
|
0
|
|
Phase B + and Phase C (Weeks 9 to 14)
Subjects Withdrew Consent
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)
Baseline characteristics by cohort
| Measure |
Phase B: Single-blind Prospective Treatment Phase
n=137 Participants
Escitalopram 10 mg capsule, orally, once daily increased to 20 mg/day at the Week 1 (end of Week 1) based upon tolerability profile, for 8 weeks. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the end of the Phase B (Week 8) entered Phase C and the rest of the participants continued to Phase B+.
|
|---|---|
|
Age, Continuous
|
43.3 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
129 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
90 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8 to Week 14Population: Intent-to-treat (ITT) Sample included all participants in the Randomized Sample who received at least one dose of double blind trial medication and had at least one post-randomization efficacy evaluation in Phase C.
The MADRS assessed severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms). Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. Last observation carried forward (LOCF) method was used for analyses.
Outcome measures
| Measure |
Phase C: Aripiprazole/Escitalopram Combination
n=16 Participants
Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily in combination with the escitalopram 10 or 20 mg orally for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram during Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated.
|
Phase C: Escitalopram Monotherapy
n=14 Participants
Participants with incomplete response at Week 8 who were randomized to this arm group received escitalopram monotherapy 10 or 20 mg capsule, orally, once daily, whichever dose was taken during the final week of Phase B for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
|
Phase C: Aripiprazole Monotherapy
n=15 Participants
Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily for 6 weeks (Up to Week 14), in Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated. No dose increments were allowed after Week 12; however, doses may have been decreased at any visit, based upon tolerability.
|
|---|---|---|---|
|
Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14)
|
-9.0 score on a scale
Standard Error 2.1
|
-3.6 score on a scale
Standard Error 2.2
|
-3.8 score on a scale
Standard Error 2.1
|
SECONDARY outcome
Timeframe: Week 14Population: ITT Sample included all participants in the Randomized Sample who received at least one dose of double blind trial medication and had at least one post-randomization efficacy evaluation in Phase C.
CGI-I is a 7-point clinician-rated scale ranging from 1 to 7, rated as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. A higher score indicates greater impairment. LOCF method was used for analyses.
Outcome measures
| Measure |
Phase C: Aripiprazole/Escitalopram Combination
n=16 Participants
Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily in combination with the escitalopram 10 or 20 mg orally for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram during Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated.
|
Phase C: Escitalopram Monotherapy
n=14 Participants
Participants with incomplete response at Week 8 who were randomized to this arm group received escitalopram monotherapy 10 or 20 mg capsule, orally, once daily, whichever dose was taken during the final week of Phase B for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
|
Phase C: Aripiprazole Monotherapy
n=15 Participants
Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily for 6 weeks (Up to Week 14), in Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated. No dose increments were allowed after Week 12; however, doses may have been decreased at any visit, based upon tolerability.
|
|---|---|---|---|
|
Phase C: Clinical Global Impression - Improvement Scale (CGI-I) Score at the End of Phase C
|
2.5 score on a scale
Standard Error 0.2
|
3.0 score on a scale
Standard Error 0.2
|
2.9 score on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Week 8 to Week 14Population: ITT Sample included all participants in the Randomized Sample who received at least one dose of double blind trial medication and had at least one post-randomization efficacy evaluation in Phase C. Overall number of participants analyzed are participants with data available for analyses.
SDS is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. The participant is asked to rate the degree to which their functioning is impaired on an 11-point scale, ranging from 0 (not at all) to 10 (extremely). Scores of 0 to 3 indicate mild functional impairment, 4 to 6 indicate moderate functional impairment, and 7 to 9 indicate marked functional impairment. The scores for the 3 domains are summed into a total score that ranges from 0 (unimpaired) to 30 (highly impaired). A higher score indicates greater impairment. A negative change score indicates improvement. LOCF method was used for analyses.
Outcome measures
| Measure |
Phase C: Aripiprazole/Escitalopram Combination
n=14 Participants
Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily in combination with the escitalopram 10 or 20 mg orally for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram during Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated.
|
Phase C: Escitalopram Monotherapy
n=13 Participants
Participants with incomplete response at Week 8 who were randomized to this arm group received escitalopram monotherapy 10 or 20 mg capsule, orally, once daily, whichever dose was taken during the final week of Phase B for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
|
Phase C: Aripiprazole Monotherapy
n=14 Participants
Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily for 6 weeks (Up to Week 14), in Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated. No dose increments were allowed after Week 12; however, doses may have been decreased at any visit, based upon tolerability.
|
|---|---|---|---|
|
Phase C: Mean Change From End of Phase B (Week 8) in the Sheehan Disability Scale (SDS) Mean Score to End of Phase C (Week 14)
|
-1.6 score on a scale
Standard Error 0.7
|
-1.8 score on a scale
Standard Error 0.7
|
-0.6 score on a scale
Standard Error 0.7
|
Adverse Events
Phase B: Single-blind Prospective Treatment Phase
Serious events: 0 serious events
Other events: 65 other events
Deaths: 0 deaths
Phase B+: Single-blind Phase B Responders
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase C: Aripiprazole/Escitalopram Combination
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Phase C: Escitalopram Monotherapy
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Phase C: Aripiprazole Monotherapy
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase B: Single-blind Prospective Treatment Phase
n=137 participants at risk
Escitalopram 10 mg capsule, orally, once daily increased to 20 mg/day at the Week 1 (end of Week 1) based upon tolerability profile, for 8 weeks. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the end of the Phase B (Week 8) entered Phase C and the rest of the participants continued to Phase B+.
|
Phase B+: Single-blind Phase B Responders
n=26 participants at risk
Participants with response (≥50% reduction in depressive symptom severity in HAM-D17 Total Score; or a HAM-D17 Total Score of \<14 at Week 8 or a Clinical Global Impression of Improvement (CGI-I) Score of \<3 at the Week 6 or 8) at the end of the Phase B (Week 8) continued treatment with the single-blind escitalopram monotherapy at the dose (10 or 20 mg/day) taken during the final week of Phase B, for an additional 6 weeks (Up to Week 14), in Phase B+.
|
Phase C: Aripiprazole/Escitalopram Combination
n=16 participants at risk
Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily in combination with the escitalopram 10 or 20 mg orally for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram during Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated.
|
Phase C: Escitalopram Monotherapy
n=14 participants at risk
Participants with incomplete response at Week 8 who were randomized to this arm group received escitalopram monotherapy 10 or 20 mg capsule, orally, once daily, whichever dose was taken during the final week of Phase B for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
|
Phase C: Aripiprazole Monotherapy
n=15 participants at risk
Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily for 6 weeks (Up to Week 14), in Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated. No dose increments were allowed after Week 12; however, doses may have been decreased at any visit, based upon tolerability.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
5.1%
7/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
3.8%
1/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.2%
1/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
20.0%
3/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Gastrointestinal disorders
Nausea
|
13.1%
18/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
7.7%
2/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
12.5%
2/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
13.3%
2/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
General disorders
Asthenia
|
0.73%
1/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
12.5%
2/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.7%
1/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
General disorders
Fatigue
|
5.1%
7/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.2%
1/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
14.3%
2/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.7%
1/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
3/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
18.8%
3/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Nervous system disorders
Akathisia
|
0.73%
1/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
12.5%
2/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.7%
1/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Nervous system disorders
Dizziness
|
6.6%
9/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
12.5%
2/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.7%
1/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Nervous system disorders
Headache
|
10.9%
15/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.2%
1/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
13.3%
2/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Nervous system disorders
Lethargy
|
1.5%
2/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.2%
1/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.7%
1/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Psychiatric disorders
Insomnia
|
1.5%
2/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.2%
1/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
13.3%
2/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Psychiatric disorders
Restlessness
|
1.5%
2/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
12.5%
2/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
26.7%
4/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Cardiac disorders
Tachycardia
|
0.73%
1/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Eye disorders
Dry eye
|
0.00%
0/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.2%
1/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Eye disorders
Vision blurred
|
0.73%
1/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.2%
1/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Gastrointestinal disorders
Flatulence
|
0.73%
1/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.7%
1/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.2%
1/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Gastrointestinal disorders
Vomiting
|
0.73%
1/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.2%
1/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
General disorders
Irritability
|
1.5%
2/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.2%
1/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.7%
1/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Infections and infestations
Bronchitis
|
0.73%
1/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.7%
1/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Infections and infestations
Viral infection
|
0.00%
0/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.7%
1/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.2%
1/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.7%
1/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.73%
1/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Investigations
Weight increased
|
1.5%
2/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.7%
1/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
2/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.2%
1/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.00%
0/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.2%
1/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.73%
1/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.7%
1/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.7%
1/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.7%
1/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Nervous system disorders
Ataxia
|
0.73%
1/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.2%
1/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Nervous system disorders
Drooling
|
0.00%
0/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.7%
1/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.7%
1/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Nervous system disorders
Paraesthesia
|
0.73%
1/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.2%
1/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Nervous system disorders
Sedation
|
1.5%
2/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.2%
1/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Nervous system disorders
Somnolence
|
5.8%
8/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
3.8%
1/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.2%
1/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
20.0%
3/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Nervous system disorders
Tremor
|
2.2%
3/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
12.5%
2/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.7%
1/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Psychiatric disorders
Anxiety
|
0.73%
1/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.7%
1/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Psychiatric disorders
Libido decreased
|
0.73%
1/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.2%
1/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.00%
0/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.2%
1/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
1.5%
2/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.7%
1/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.2%
3/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
6.2%
1/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
|
Vascular disorders
Hot flush
|
0.00%
0/137 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/26 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/16 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
0.00%
0/15 • From first dose of study drug through 30 days after the last dose of study drug (up to approximately 22 weeks)
Phase B Sample included all participants who took at least one dose of escitalopram as indicated on the dosing record. Phase B+ Sample included all participants who responded at the end of Phase B (were therefore not randomized) and who continued on single-blind escitalopram beyond Week 8. Randomized Sample included all participants who were randomized in Phase C.
|
Additional Information
Global Clinical Development
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phone: 1-609-524-6788
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right to review results publications prior to public release and can delay such publications for a period greater than 60 days but no more than 120 days from the date that the publication is submitted to the Sponsor for review. Sponsor can require changes to the publication to protect Sponsor's intellectual property rights and/or confidential information and reserves the right to limit publication timing and scope of data published based on the number of study locations.
- Publication restrictions are in place
Restriction type: OTHER