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 NCT01111539)
NCT ID: NCT01111539
Last Updated: 2021-10-20
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 from Week 8 indicates improvement.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
211 participants
Primary outcome timeframe
Week 8 to Week 14
Results posted on
2021-10-20
Participant Flow
Participants took part in the study at 69 investigative sites in Estonia, Finland, Germany, India, Italy, Mexico, South Korea, Taiwan, Ukraine, and the United States from 13 July 2010 to 20 September 2011.
A total of 211 participants were enrolled in Phase B (Single-blind Prospective Treatment Phase) to receive escitalopram monotherapy(10 or 20mg/day),of which 45 responders continued to Phase B+(Single-blind Phase B Responders),received escitalopram monotherapy(10 or 20mg/day),84 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
Participants received initial dose of escitalopram 10 milligram (mg) blinded capsule (over-encapsulated tablet), orally, once daily, increased to 20 mg/day at the end of Week 1 based upon tolerability profile, for up to maximum of Week 8. 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 Hamilton Depression Rating Scale {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 blinded capsules) taken during the final week of Phase B, for up to maximum of Week 14, in Phase B+.
|
Phase C: Aripiprazole/Escitalopram Combination
Participants with incomplete response (less than 50% reduction in depressive symptom severity between Baseline and Week 8 measured by the HAM-D17 Total Score and HAM-D17 Total Score of ≥14 at Week 8 and CGI-I Score of ≥3 at Week 6 and 8) at Week 8 received initial dose of aripiprazole 6 mg blinded capsule, orally, once daily at Week 9. Participants were up titrated to aripiprazole target dose of 12 mg/day at Week 10 (if initial 6 mg/day dose was tolerated) or down titrated to 3 mg/day (if significant tolerability issues arise on initial 6 mg/day dose), and thereafter received same dose up to maximum of Week 14. No dose increases were allowed for aripiprazole after end of Week 12, however, doses might be decreased at any visit based upon tolerability. In combination with aripiprazole, participants received escitalopram (10 or 20 mg/day blinded capsules) taken during final week of Phase B for up to maximum Week 14, in Phase C. No dose adjustments allowed for escitalopram during Phase C.
|
Phase C: Escitalopram Monotherapy
Participants with incomplete response (less than a 50% reduction in depressive symptom severity between the Baseline and Week 8 as measured by the HAM-D17 Total Score and a HAM-D17 Total Score of ≥14 at Week 8 and a CGI-I Score of ≥3 at Week 6 and 8) at Week 8, received escitalopram dose (10 or 20 mg/day blinded capsules) taken during the final week of Phase B for up to maximum Week 14, in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
|
Phase C: Aripiprazole Monotherapy
Participants with incomplete response (less than a 50% reduction in depressive symptom severity between the Baseline and Week 8 as measured by the HAM-D17 Total Score and a HAM-D17 Total Score of ≥14 at Week 8 and a CGI-I Score of ≥3 at Week 6 and 8) at Week 8, received initial dose of aripiprazole 6 mg blinded capsule, orally, once daily for Week 9. Participants were up titrated to the aripiprazole target dose of 12 mg/day at Week 10 (if the initial 6 mg/day dose was tolerated) or down titrated to 3 mg/day (if significant tolerability issues arise on the initial 6 mg/day dose), and thereafter received the same dose for up to maximum of Week 14. No dose increases were allowed for aripiprazole after the end of Week 12, however, doses might be decreased at any visit based upon tolerability.
|
|---|---|---|---|---|---|
|
Phase B (Day 1 to Week 8)
STARTED
|
211
|
0
|
0
|
0
|
0
|
|
Phase B (Day 1 to Week 8)
COMPLETED
|
129
|
0
|
0
|
0
|
0
|
|
Phase B (Day 1 to Week 8)
NOT COMPLETED
|
82
|
0
|
0
|
0
|
0
|
|
Phase B+ and Phase C (Weeks 9 to 14)
STARTED
|
0
|
45
|
28
|
28
|
28
|
|
Phase B+ and Phase C (Weeks 9 to 14)
Intent-to-treat (ITT) Sample
|
0
|
45
|
28
|
27
|
28
|
|
Phase B+ and Phase C (Weeks 9 to 14)
Safety Sample
|
0
|
45
|
28
|
27
|
28
|
|
Phase B+ and Phase C (Weeks 9 to 14)
COMPLETED
|
0
|
38
|
22
|
20
|
18
|
|
Phase B+ and Phase C (Weeks 9 to 14)
NOT COMPLETED
|
0
|
7
|
6
|
8
|
10
|
Reasons for withdrawal
| Measure |
Phase B: Single-blind Prospective Treatment Phase
Participants received initial dose of escitalopram 10 milligram (mg) blinded capsule (over-encapsulated tablet), orally, once daily, increased to 20 mg/day at the end of Week 1 based upon tolerability profile, for up to maximum of Week 8. 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 Hamilton Depression Rating Scale {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 blinded capsules) taken during the final week of Phase B, for up to maximum of Week 14, in Phase B+.
|
Phase C: Aripiprazole/Escitalopram Combination
Participants with incomplete response (less than 50% reduction in depressive symptom severity between Baseline and Week 8 measured by the HAM-D17 Total Score and HAM-D17 Total Score of ≥14 at Week 8 and CGI-I Score of ≥3 at Week 6 and 8) at Week 8 received initial dose of aripiprazole 6 mg blinded capsule, orally, once daily at Week 9. Participants were up titrated to aripiprazole target dose of 12 mg/day at Week 10 (if initial 6 mg/day dose was tolerated) or down titrated to 3 mg/day (if significant tolerability issues arise on initial 6 mg/day dose), and thereafter received same dose up to maximum of Week 14. No dose increases were allowed for aripiprazole after end of Week 12, however, doses might be decreased at any visit based upon tolerability. In combination with aripiprazole, participants received escitalopram (10 or 20 mg/day blinded capsules) taken during final week of Phase B for up to maximum Week 14, in Phase C. No dose adjustments allowed for escitalopram during Phase C.
|
Phase C: Escitalopram Monotherapy
Participants with incomplete response (less than a 50% reduction in depressive symptom severity between the Baseline and Week 8 as measured by the HAM-D17 Total Score and a HAM-D17 Total Score of ≥14 at Week 8 and a CGI-I Score of ≥3 at Week 6 and 8) at Week 8, received escitalopram dose (10 or 20 mg/day blinded capsules) taken during the final week of Phase B for up to maximum Week 14, in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
|
Phase C: Aripiprazole Monotherapy
Participants with incomplete response (less than a 50% reduction in depressive symptom severity between the Baseline and Week 8 as measured by the HAM-D17 Total Score and a HAM-D17 Total Score of ≥14 at Week 8 and a CGI-I Score of ≥3 at Week 6 and 8) at Week 8, received initial dose of aripiprazole 6 mg blinded capsule, orally, once daily for Week 9. Participants were up titrated to the aripiprazole target dose of 12 mg/day at Week 10 (if the initial 6 mg/day dose was tolerated) or down titrated to 3 mg/day (if significant tolerability issues arise on the initial 6 mg/day dose), and thereafter received the same dose for up to maximum of Week 14. No dose increases were allowed for aripiprazole after the end of Week 12, however, doses might be decreased at any visit based upon tolerability.
|
|---|---|---|---|---|---|
|
Phase B (Day 1 to Week 8)
Lost to Follow-up
|
6
|
0
|
0
|
0
|
0
|
|
Phase B (Day 1 to Week 8)
Adverse Event
|
5
|
0
|
0
|
0
|
0
|
|
Phase B (Day 1 to Week 8)
Sponsor Discontinued Study
|
60
|
0
|
0
|
0
|
0
|
|
Phase B (Day 1 to Week 8)
Investigator Withdrew Subject
|
1
|
0
|
0
|
0
|
0
|
|
Phase B (Day 1 to Week 8)
Subject Withdrew Consent
|
7
|
0
|
0
|
0
|
0
|
|
Phase B (Day 1 to Week 8)
Protocol Deviation
|
2
|
0
|
0
|
0
|
0
|
|
Phase B (Day 1 to Week 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
|
1
|
0
|
1
|
|
Phase B+ and Phase C (Weeks 9 to 14)
Adverse Event
|
0
|
0
|
1
|
0
|
2
|
|
Phase B+ and Phase C (Weeks 9 to 14)
Sponsor Discontinued Study
|
0
|
7
|
4
|
5
|
5
|
|
Phase B+ and Phase C (Weeks 9 to 14)
Subject Met Withdrawal Criteria
|
0
|
0
|
0
|
0
|
1
|
|
Phase B+ and Phase C (Weeks 9 to 14)
Investigator Withdrew Subject
|
0
|
0
|
0
|
1
|
0
|
|
Phase B+ and Phase C (Weeks 9 to 14)
Subject Withdrew Consent
|
0
|
0
|
0
|
2
|
0
|
|
Phase B+ and Phase C (Weeks 9 to 14)
Protocol Deviation
|
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=211 Participants
Participants received initial dose of escitalopram 10 milligram (mg) blinded capsule (over-encapsulated tablet), orally, once daily, increased to 20 mg/day at the end of Week 1 based upon tolerability profile, for up to maximum of Week 8. 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
|
44.4 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
168 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
36 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
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
130 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
PRIMARY 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 study medication and had at least one post-randomization efficacy evaluation.
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 from Week 8 indicates improvement.
Outcome measures
| Measure |
Phase C: Aripiprazole/Escitalopram Combination
n=28 Participants
Participants with incomplete response (less than 50% reduction in depressive symptom severity between Baseline and Week 8 measured by the HAM-D17 Total Score and HAM-D17 Total Score of ≥14 at Week 8 and CGI-I Score of ≥3 at Week 6 and 8) at Week 8 received initial dose of aripiprazole 6 mg blinded capsule, orally, once daily at Week 9. Participants were up titrated to aripiprazole target dose of 12 mg/day at Week 10 (if initial 6 mg/day dose was tolerated) or down titrated to 3 mg/day (if significant tolerability issues arise on initial 6 mg/day dose), and thereafter received same dose up to maximum of Week 14. No dose increases were allowed for aripiprazole after end of Week 12, however, doses might be decreased at any visit based upon tolerability. In combination with aripiprazole, participants received escitalopram (10 or 20 mg/day blinded capsules) taken during final week of Phase B for up to maximum Week 14, in Phase C. No dose adjustments allowed for escitalopram during Phase C.
|
Phase C: Escitalopram Monotherapy
n=27 Participants
Participants with incomplete response (less than a 50% reduction in depressive symptom severity between the Baseline and Week 8 as measured by the HAM-D17 Total Score and a HAM-D17 Total Score of ≥14 at Week 8 and a CGI-I Score of ≥3 at Week 6 and 8) at Week 8, received escitalopram dose (10 or 20 mg/day blinded capsules) taken during the final week of Phase B for up to maximum Week 14, in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
|
Phase C: Aripiprazole Monotherapy
n=28 Participants
Participants with incomplete response (less than a 50% reduction in depressive symptom severity between the Baseline and Week 8 as measured by the HAM-D17 Total Score and a HAM-D17 Total Score of ≥14 at Week 8 and a CGI-I Score of ≥3 at Week 6 and 8) at Week 8, received initial dose of aripiprazole 6 mg blinded capsule, orally, once daily for Week 9. Participants were up titrated to the aripiprazole target dose of 12 mg/day at Week 10 (if the initial 6 mg/day dose was tolerated) or down titrated to 3 mg/day (if significant tolerability issues arise on the initial 6 mg/day dose), and thereafter received the same dose for up to maximum of Week 14. No dose increases were allowed for aripiprazole after the end of Week 12, however, doses might be 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)
|
-8.0 score on a scale
Standard Error 1.5
|
-7.0 score on a scale
Standard Error 1.5
|
-4.3 score on a scale
Standard Error 1.5
|
SECONDARY outcome
Timeframe: Week 14Population: ITT Sample included all participants in the Randomized Sample who received at least one dose of double-blind study medication and had at least one post-randomization efficacy evaluation.
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.
Outcome measures
| Measure |
Phase C: Aripiprazole/Escitalopram Combination
n=28 Participants
Participants with incomplete response (less than 50% reduction in depressive symptom severity between Baseline and Week 8 measured by the HAM-D17 Total Score and HAM-D17 Total Score of ≥14 at Week 8 and CGI-I Score of ≥3 at Week 6 and 8) at Week 8 received initial dose of aripiprazole 6 mg blinded capsule, orally, once daily at Week 9. Participants were up titrated to aripiprazole target dose of 12 mg/day at Week 10 (if initial 6 mg/day dose was tolerated) or down titrated to 3 mg/day (if significant tolerability issues arise on initial 6 mg/day dose), and thereafter received same dose up to maximum of Week 14. No dose increases were allowed for aripiprazole after end of Week 12, however, doses might be decreased at any visit based upon tolerability. In combination with aripiprazole, participants received escitalopram (10 or 20 mg/day blinded capsules) taken during final week of Phase B for up to maximum Week 14, in Phase C. No dose adjustments allowed for escitalopram during Phase C.
|
Phase C: Escitalopram Monotherapy
n=27 Participants
Participants with incomplete response (less than a 50% reduction in depressive symptom severity between the Baseline and Week 8 as measured by the HAM-D17 Total Score and a HAM-D17 Total Score of ≥14 at Week 8 and a CGI-I Score of ≥3 at Week 6 and 8) at Week 8, received escitalopram dose (10 or 20 mg/day blinded capsules) taken during the final week of Phase B for up to maximum Week 14, in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
|
Phase C: Aripiprazole Monotherapy
n=28 Participants
Participants with incomplete response (less than a 50% reduction in depressive symptom severity between the Baseline and Week 8 as measured by the HAM-D17 Total Score and a HAM-D17 Total Score of ≥14 at Week 8 and a CGI-I Score of ≥3 at Week 6 and 8) at Week 8, received initial dose of aripiprazole 6 mg blinded capsule, orally, once daily for Week 9. Participants were up titrated to the aripiprazole target dose of 12 mg/day at Week 10 (if the initial 6 mg/day dose was tolerated) or down titrated to 3 mg/day (if significant tolerability issues arise on the initial 6 mg/day dose), and thereafter received the same dose for up to maximum of Week 14. No dose increases were allowed for aripiprazole after the end of Week 12, however, doses might be decreased at any visit based upon tolerability.
|
|---|---|---|---|
|
Phase C: Mean Clinical Global Impression - Improvement (CGI-I) Scale Score at the End of Phase C (Week 14)
|
2.6 score on a scale
Standard Error 0.2
|
2.9 score on a scale
Standard Error 0.2
|
3.0 score on a scale
Standard Error 0.1
|
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 study medication and had at least one post-randomization efficacy evaluation. Overall number of participants analyzed are the participants with evaluable data 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). 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 from Week 8 indicates improvement.
Outcome measures
| Measure |
Phase C: Aripiprazole/Escitalopram Combination
n=27 Participants
Participants with incomplete response (less than 50% reduction in depressive symptom severity between Baseline and Week 8 measured by the HAM-D17 Total Score and HAM-D17 Total Score of ≥14 at Week 8 and CGI-I Score of ≥3 at Week 6 and 8) at Week 8 received initial dose of aripiprazole 6 mg blinded capsule, orally, once daily at Week 9. Participants were up titrated to aripiprazole target dose of 12 mg/day at Week 10 (if initial 6 mg/day dose was tolerated) or down titrated to 3 mg/day (if significant tolerability issues arise on initial 6 mg/day dose), and thereafter received same dose up to maximum of Week 14. No dose increases were allowed for aripiprazole after end of Week 12, however, doses might be decreased at any visit based upon tolerability. In combination with aripiprazole, participants received escitalopram (10 or 20 mg/day blinded capsules) taken during final week of Phase B for up to maximum Week 14, in Phase C. No dose adjustments allowed for escitalopram during Phase C.
|
Phase C: Escitalopram Monotherapy
n=25 Participants
Participants with incomplete response (less than a 50% reduction in depressive symptom severity between the Baseline and Week 8 as measured by the HAM-D17 Total Score and a HAM-D17 Total Score of ≥14 at Week 8 and a CGI-I Score of ≥3 at Week 6 and 8) at Week 8, received escitalopram dose (10 or 20 mg/day blinded capsules) taken during the final week of Phase B for up to maximum Week 14, in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
|
Phase C: Aripiprazole Monotherapy
n=26 Participants
Participants with incomplete response (less than a 50% reduction in depressive symptom severity between the Baseline and Week 8 as measured by the HAM-D17 Total Score and a HAM-D17 Total Score of ≥14 at Week 8 and a CGI-I Score of ≥3 at Week 6 and 8) at Week 8, received initial dose of aripiprazole 6 mg blinded capsule, orally, once daily for Week 9. Participants were up titrated to the aripiprazole target dose of 12 mg/day at Week 10 (if the initial 6 mg/day dose was tolerated) or down titrated to 3 mg/day (if significant tolerability issues arise on the initial 6 mg/day dose), and thereafter received the same dose for up to maximum of Week 14. No dose increases were allowed for aripiprazole after the end of Week 12, however, doses might be 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)
|
-1.2 score on a scale
Standard Error 0.4
|
-1.2 score on a scale
Standard Error 0.4
|
-0.2 score on a scale
Standard Error 0.4
|
Adverse Events
Phase B: Single-blind Prospective Treatment Phase
Serious events: 2 serious events
Other events: 82 other events
Deaths: 0 deaths
Phase B+: Single-blind Phase B Responders
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase C: Aripiprazole/Escitalopram Combination
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Phase C: Escitalopram Monotherapy
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Phase C: Aripiprazole Monotherapy
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase B: Single-blind Prospective Treatment Phase
n=211 participants at risk
Participants received initial dose of escitalopram 10 milligram (mg) blinded capsule (over-encapsulated tablet), orally, once daily, increased to 20 mg/day at the end of Week 1 based upon tolerability profile, for up to maximum of Week 8. 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=45 participants at risk
Participants with response (≥50% reduction in depressive symptom severity in Hamilton Depression Rating Scale {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 blinded capsules) taken during the final week of Phase B, for up to maximum of Week 14, in Phase B+.
|
Phase C: Aripiprazole/Escitalopram Combination
n=28 participants at risk
Participants with incomplete response (less than 50% reduction in depressive symptom severity between Baseline and Week 8 measured by the HAM-D17 Total Score and HAM-D17 Total Score of ≥14 at Week 8 and CGI-I Score of ≥3 at Week 6 and 8) at Week 8 received initial dose of aripiprazole 6 mg blinded capsule, orally, once daily at Week 9. Participants were up titrated to aripiprazole target dose of 12 mg/day at Week 10 (if initial 6 mg/day dose was tolerated) or down titrated to 3 mg/day (if significant tolerability issues arise on initial 6 mg/day dose), and thereafter received same dose up to maximum of Week 14. No dose increases were allowed for aripiprazole after end of Week 12, however, doses might be decreased at any visit based upon tolerability. In combination with aripiprazole, participants received escitalopram (10 or 20 mg/day blinded capsules) taken during final week of Phase B for up to maximum Week 14, in Phase C. No dose adjustments allowed for escitalopram during Phase C.
|
Phase C: Escitalopram Monotherapy
n=27 participants at risk
Participants with incomplete response (less than a 50% reduction in depressive symptom severity between the Baseline and Week 8 as measured by the HAM-D17 Total Score and a HAM-D17 Total Score of ≥14 at Week 8 and a CGI-I Score of ≥3 at Week 6 and 8) at Week 8, received escitalopram dose (10 or 20 mg/day blinded capsules) taken during the final week of Phase B for up to maximum Week 14, in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
|
Phase C: Aripiprazole Monotherapy
n=28 participants at risk
Participants with incomplete response (less than a 50% reduction in depressive symptom severity between the Baseline and Week 8 as measured by the HAM-D17 Total Score and a HAM-D17 Total Score of ≥14 at Week 8 and a CGI-I Score of ≥3 at Week 6 and 8) at Week 8, received initial dose of aripiprazole 6 mg blinded capsule, orally, once daily for Week 9. Participants were up titrated to the aripiprazole target dose of 12 mg/day at Week 10 (if the initial 6 mg/day dose was tolerated) or down titrated to 3 mg/day (if significant tolerability issues arise on the initial 6 mg/day dose), and thereafter received the same dose for up to maximum of Week 14. No dose increases were allowed for aripiprazole after the end of Week 12, however, doses might be decreased at any visit based upon tolerability.
|
|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
3.7%
1/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
Nervous system disorders
Syncope
|
0.00%
0/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
3.6%
1/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
3.6%
1/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
Injury, poisoning and procedural complications
Fall
|
0.47%
1/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.47%
1/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
Psychiatric disorders
Suicidal ideation
|
0.47%
1/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
Other adverse events
| Measure |
Phase B: Single-blind Prospective Treatment Phase
n=211 participants at risk
Participants received initial dose of escitalopram 10 milligram (mg) blinded capsule (over-encapsulated tablet), orally, once daily, increased to 20 mg/day at the end of Week 1 based upon tolerability profile, for up to maximum of Week 8. 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=45 participants at risk
Participants with response (≥50% reduction in depressive symptom severity in Hamilton Depression Rating Scale {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 blinded capsules) taken during the final week of Phase B, for up to maximum of Week 14, in Phase B+.
|
Phase C: Aripiprazole/Escitalopram Combination
n=28 participants at risk
Participants with incomplete response (less than 50% reduction in depressive symptom severity between Baseline and Week 8 measured by the HAM-D17 Total Score and HAM-D17 Total Score of ≥14 at Week 8 and CGI-I Score of ≥3 at Week 6 and 8) at Week 8 received initial dose of aripiprazole 6 mg blinded capsule, orally, once daily at Week 9. Participants were up titrated to aripiprazole target dose of 12 mg/day at Week 10 (if initial 6 mg/day dose was tolerated) or down titrated to 3 mg/day (if significant tolerability issues arise on initial 6 mg/day dose), and thereafter received same dose up to maximum of Week 14. No dose increases were allowed for aripiprazole after end of Week 12, however, doses might be decreased at any visit based upon tolerability. In combination with aripiprazole, participants received escitalopram (10 or 20 mg/day blinded capsules) taken during final week of Phase B for up to maximum Week 14, in Phase C. No dose adjustments allowed for escitalopram during Phase C.
|
Phase C: Escitalopram Monotherapy
n=27 participants at risk
Participants with incomplete response (less than a 50% reduction in depressive symptom severity between the Baseline and Week 8 as measured by the HAM-D17 Total Score and a HAM-D17 Total Score of ≥14 at Week 8 and a CGI-I Score of ≥3 at Week 6 and 8) at Week 8, received escitalopram dose (10 or 20 mg/day blinded capsules) taken during the final week of Phase B for up to maximum Week 14, in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
|
Phase C: Aripiprazole Monotherapy
n=28 participants at risk
Participants with incomplete response (less than a 50% reduction in depressive symptom severity between the Baseline and Week 8 as measured by the HAM-D17 Total Score and a HAM-D17 Total Score of ≥14 at Week 8 and a CGI-I Score of ≥3 at Week 6 and 8) at Week 8, received initial dose of aripiprazole 6 mg blinded capsule, orally, once daily for Week 9. Participants were up titrated to the aripiprazole target dose of 12 mg/day at Week 10 (if the initial 6 mg/day dose was tolerated) or down titrated to 3 mg/day (if significant tolerability issues arise on the initial 6 mg/day dose), and thereafter received the same dose for up to maximum of Week 14. No dose increases were allowed for aripiprazole after the end of Week 12, however, doses might be decreased at any visit based upon tolerability.
|
|---|---|---|---|---|---|
|
Eye disorders
Photophobia
|
0.00%
0/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
7.1%
2/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
Eye disorders
Vision blurred
|
0.95%
2/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
7.1%
2/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
12/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
2.2%
1/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
7.4%
2/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
Gastrointestinal disorders
Dry mouth
|
3.8%
8/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
2.2%
1/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
3.6%
1/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
7.1%
2/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
21/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
3.6%
1/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
7.4%
2/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
14.3%
4/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
General disorders
Feeling jittery
|
0.00%
0/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
3.6%
1/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
7.1%
2/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
General disorders
Irritability
|
0.95%
2/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
7.1%
2/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
7.1%
2/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
Immune system disorders
Seasonal allergy
|
0.95%
2/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
10.7%
3/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.47%
1/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
7.4%
2/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
3.6%
1/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
7.1%
2/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
3.7%
1/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
17.9%
5/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
Nervous system disorders
Disturbance in attention
|
0.47%
1/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
7.1%
2/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
Nervous system disorders
Dizziness
|
2.8%
6/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
3.6%
1/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
7.1%
2/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
7.1%
2/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
Nervous system disorders
Headache
|
17.1%
36/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
2.2%
1/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
7.1%
2/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
7.4%
2/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
14.3%
4/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
Nervous system disorders
Sedation
|
1.4%
3/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
7.1%
2/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
14.3%
4/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
Nervous system disorders
Somnolence
|
5.7%
12/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
10.7%
3/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
11.1%
3/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
3.6%
1/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
Psychiatric disorders
Insomnia
|
1.9%
4/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
10.7%
3/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
7.4%
2/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
3.6%
1/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
Psychiatric disorders
Restlessness
|
0.47%
1/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
14.3%
4/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
3.7%
1/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
7.1%
2/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/211 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/45 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
0.00%
0/27 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
7.1%
2/28 • From first dose through 30 days after last dose of study drug (up to approximately 18 weeks)
Phase B Sample- participants who took at least one dose of escitalopram. Phase B+ Sample - participants who responded at end of Phase B (were therefore not randomized) and continued on single-blind escitalopram beyond Week 8. Safety Sample(SS) included those randomized participants in Phase C who received at least one dose of double-blind study medication. 1 participant randomized to escitalopram group, was withdrawn by investigator prior to dosing in Phase C and thus was not included in the SS.
|
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