Trial Outcomes & Findings for The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone (NCT NCT03739203)
NCT ID: NCT03739203
Last Updated: 2022-09-21
Results Overview
The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants were rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item was scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change from Baseline indicates improvement. Mixed-effects Model for Repeated Measures (MMRM) was used for analyses.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
752 participants
Primary outcome timeframe
Baseline and Week 6
Results posted on
2022-09-21
Participant Flow
A total of 752 participants were enrolled, of which 751 took ≥1 dose of double-blind investigational product and were included in the Safety Population. One participant was randomized but did not receive treatment and was excluded from the study analyses. At the end of treatment in the Double-blind Period, participants continued on their background antidepressant therapy (ADT) and entered the Safety Follow-up Period.
Participant milestones
| Measure |
Placebo + ADT
Cariprazine matching placebo capsules, orally, once daily in addition to their ongoing antidepressant therapy (ADT) \[same antidepressant and dose of ADT they were on at the Baseline\] during the Double-blind Treatment Period, up to Week 6.
|
Cariprazine 1.5 mg/Day + ADT
Cariprazine 1.5 mg capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.
|
Cariprazine 3 mg/Day + ADT
Cariprazine 1.5 mg capsules, orally, once daily for 2 weeks starting at the Baseline, titrated to 3.0 mg capsules, orally, once daily from Week 2 through Week 6 in addition to their ongoing ADT (same antidepressant and dose of ADT) during the Double-blind Treatment Period, up to Week 6.
|
|---|---|---|---|
|
Double-blind Treatment Period (6 Weeks)
STARTED
|
250
|
250
|
251
|
|
Double-blind Treatment Period (6 Weeks)
Modified Intent-to Treat (mITT) Population
|
249
|
250
|
251
|
|
Double-blind Treatment Period (6 Weeks)
COMPLETED
|
235
|
233
|
226
|
|
Double-blind Treatment Period (6 Weeks)
NOT COMPLETED
|
15
|
17
|
25
|
|
Safety Follow-Up Period (4 Weeks)
STARTED
|
242
|
242
|
242
|
|
Safety Follow-Up Period (4 Weeks)
COMPLETED
|
240
|
240
|
238
|
|
Safety Follow-Up Period (4 Weeks)
NOT COMPLETED
|
2
|
2
|
4
|
Reasons for withdrawal
| Measure |
Placebo + ADT
Cariprazine matching placebo capsules, orally, once daily in addition to their ongoing antidepressant therapy (ADT) \[same antidepressant and dose of ADT they were on at the Baseline\] during the Double-blind Treatment Period, up to Week 6.
|
Cariprazine 1.5 mg/Day + ADT
Cariprazine 1.5 mg capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.
|
Cariprazine 3 mg/Day + ADT
Cariprazine 1.5 mg capsules, orally, once daily for 2 weeks starting at the Baseline, titrated to 3.0 mg capsules, orally, once daily from Week 2 through Week 6 in addition to their ongoing ADT (same antidepressant and dose of ADT) during the Double-blind Treatment Period, up to Week 6.
|
|---|---|---|---|
|
Double-blind Treatment Period (6 Weeks)
Adverse Event
|
6
|
9
|
13
|
|
Double-blind Treatment Period (6 Weeks)
Lack of Efficacy
|
1
|
0
|
1
|
|
Double-blind Treatment Period (6 Weeks)
Lost to Follow-up
|
1
|
1
|
2
|
|
Double-blind Treatment Period (6 Weeks)
Withdrawal by Subject
|
4
|
4
|
6
|
|
Double-blind Treatment Period (6 Weeks)
Protocol Deviation
|
1
|
0
|
1
|
|
Double-blind Treatment Period (6 Weeks)
Non-compliance With Study Drug
|
1
|
3
|
1
|
|
Double-blind Treatment Period (6 Weeks)
Reason not Specified
|
1
|
0
|
1
|
|
Safety Follow-Up Period (4 Weeks)
Withdrawal by Subject
|
1
|
2
|
0
|
|
Safety Follow-Up Period (4 Weeks)
Lost to Follow-up
|
0
|
0
|
2
|
|
Safety Follow-Up Period (4 Weeks)
Death
|
1
|
0
|
0
|
|
Safety Follow-Up Period (4 Weeks)
Reason not Specified
|
0
|
0
|
2
|
Baseline Characteristics
mITT Population included all randomized participants who had ≥1 postbaseline assessment of the MADRS total score.
Baseline characteristics by cohort
| Measure |
Placebo + ADT
n=250 Participants
Cariprazine matching placebo capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.
|
Cariprazine 1.5 mg/Day + ADT
n=250 Participants
Cariprazine 1.5 mg capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.
|
Cariprazine 3 mg/Day + ADT
n=251 Participants
Cariprazine 1.5 mg capsules, orally, once daily for 2 weeks starting at the Baseline, titrated to 3.0 mg capsules, orally, once daily from Week 2 through Week 6 in addition to their ongoing ADT (same antidepressant and dose of ADT) during the Double-blind Treatment Period, up to Week 6.
|
Total
n=751 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 12.12 • n=250 Participants
|
45.0 years
STANDARD_DEVIATION 12.95 • n=250 Participants
|
45.8 years
STANDARD_DEVIATION 12.45 • n=251 Participants
|
45.7 years
STANDARD_DEVIATION 12.51 • n=751 Participants
|
|
Sex: Female, Male
Female
|
191 Participants
n=250 Participants
|
185 Participants
n=250 Participants
|
197 Participants
n=251 Participants
|
573 Participants
n=751 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=250 Participants
|
65 Participants
n=250 Participants
|
54 Participants
n=251 Participants
|
178 Participants
n=751 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=250 Participants
|
38 Participants
n=250 Participants
|
34 Participants
n=251 Participants
|
102 Participants
n=751 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
220 Participants
n=250 Participants
|
212 Participants
n=250 Participants
|
217 Participants
n=251 Participants
|
649 Participants
n=751 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=250 Participants
|
0 Participants
n=250 Participants
|
0 Participants
n=251 Participants
|
0 Participants
n=751 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=250 Participants
|
0 Participants
n=250 Participants
|
2 Participants
n=251 Participants
|
2 Participants
n=751 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=250 Participants
|
0 Participants
n=250 Participants
|
5 Participants
n=251 Participants
|
9 Participants
n=751 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=250 Participants
|
1 Participants
n=250 Participants
|
0 Participants
n=251 Participants
|
1 Participants
n=751 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=250 Participants
|
32 Participants
n=250 Participants
|
22 Participants
n=251 Participants
|
83 Participants
n=751 Participants
|
|
Race (NIH/OMB)
White
|
217 Participants
n=250 Participants
|
216 Participants
n=250 Participants
|
221 Participants
n=251 Participants
|
654 Participants
n=751 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=250 Participants
|
1 Participants
n=250 Participants
|
1 Participants
n=251 Participants
|
2 Participants
n=751 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=250 Participants
|
0 Participants
n=250 Participants
|
0 Participants
n=251 Participants
|
0 Participants
n=751 Participants
|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
|
32.99 score on a scale
STANDARD_DEVIATION 4.789 • n=249 Participants • mITT Population included all randomized participants who had ≥1 postbaseline assessment of the MADRS total score.
|
32.00 score on a scale
STANDARD_DEVIATION 4.246 • n=250 Participants • mITT Population included all randomized participants who had ≥1 postbaseline assessment of the MADRS total score.
|
32.25 score on a scale
STANDARD_DEVIATION 4.688 • n=251 Participants • mITT Population included all randomized participants who had ≥1 postbaseline assessment of the MADRS total score.
|
32.41 score on a scale
STANDARD_DEVIATION 4.593 • n=750 Participants • mITT Population included all randomized participants who had ≥1 postbaseline assessment of the MADRS total score.
|
|
Clinical Global Impression-Severity (CGI-S) Scale Score
|
4.67 score on a scale
STANDARD_DEVIATION 0.599 • n=249 Participants • mITT Population included all randomized participants who had ≥1 postbaseline assessment of the MADRS total score.
|
4.61 score on a scale
STANDARD_DEVIATION 0.586 • n=250 Participants • mITT Population included all randomized participants who had ≥1 postbaseline assessment of the MADRS total score.
|
4.65 score on a scale
STANDARD_DEVIATION 0.654 • n=251 Participants • mITT Population included all randomized participants who had ≥1 postbaseline assessment of the MADRS total score.
|
4.64 score on a scale
STANDARD_DEVIATION 0.614 • n=750 Participants • mITT Population included all randomized participants who had ≥1 postbaseline assessment of the MADRS total score.
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: mITT Population included all randomized participants who had ≥1 postbaseline assessment of the MADRS total score. Overall number of participants analyzed are the number of participants with data available for analyses.
The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants were rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item was scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change from Baseline indicates improvement. Mixed-effects Model for Repeated Measures (MMRM) was used for analyses.
Outcome measures
| Measure |
Placebo + ADT
n=236 Participants
Cariprazine matching placebo capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.
|
Cariprazine 1.5 mg/Day + ADT
n=237 Participants
Cariprazine 1.5 mg capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.
|
Cariprazine 3 mg/Day + ADT
n=231 Participants
Cariprazine 1.5 mg capsules, orally, once daily for 2 weeks starting at the Baseline, titrated to 3.0 mg capsules, orally, once daily from Week 2 through Week 6 in addition to their ongoing ADT (same antidepressant and dose of ADT) during the Double-blind Treatment Period, up to Week 6.
|
|---|---|---|---|
|
Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) Total Score
|
-13.4 score on a scale
Standard Error 0.70
|
-13.8 score on a scale
Standard Error 0.69
|
-14.8 score on a scale
Standard Error 0.70
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: mITT Population included all randomized participants who had ≥1 postbaseline assessment of the MADRS total score. Overall number of participants analyzed are the number of participants with data available for analyses.
The CGI-S is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1=normal, not at all ill and 7=among the most extremely ill participants. Higher score indicates worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analyses.
Outcome measures
| Measure |
Placebo + ADT
n=236 Participants
Cariprazine matching placebo capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.
|
Cariprazine 1.5 mg/Day + ADT
n=237 Participants
Cariprazine 1.5 mg capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.
|
Cariprazine 3 mg/Day + ADT
n=231 Participants
Cariprazine 1.5 mg capsules, orally, once daily for 2 weeks starting at the Baseline, titrated to 3.0 mg capsules, orally, once daily from Week 2 through Week 6 in addition to their ongoing ADT (same antidepressant and dose of ADT) during the Double-blind Treatment Period, up to Week 6.
|
|---|---|---|---|
|
Change From Baseline to Week 6 in the Clinical Global Impressions-Severity (CGI-S) Score
|
-1.4 score on a scale
Standard Error 0.09
|
-1.4 score on a scale
Standard Error 0.09
|
-1.6 score on a scale
Standard Error 0.09
|
Adverse Events
Placebo + ADT
Serious events: 2 serious events
Other events: 54 other events
Deaths: 1 deaths
Cariprazine 1.5 mg/Day + ADT
Serious events: 3 serious events
Other events: 70 other events
Deaths: 0 deaths
Cariprazine 3 mg/Day + ADT
Serious events: 1 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + ADT
n=250 participants at risk
Cariprazine matching placebo capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.
|
Cariprazine 1.5 mg/Day + ADT
n=250 participants at risk
Cariprazine 1.5 mg capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.
|
Cariprazine 3 mg/Day + ADT
n=251 participants at risk
Cariprazine 1.5 mg capsules, orally, once daily for 2 weeks starting at the Baseline, titrated to 3.0 mg capsules, orally, once daily from Week 2 through Week 6 in addition to their ongoing ADT (same antidepressant and dose of ADT) during the Double-blind Treatment Period, up to Week 6.
|
|---|---|---|---|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/250 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
0.00%
0/250 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
0.40%
1/251 • Number of events 1 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.40%
1/250 • Number of events 1 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
0.00%
0/250 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
0.00%
0/251 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
|
General disorders
DEATH
|
0.40%
1/250 • Number of events 1 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
0.00%
0/250 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
0.00%
0/251 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
|
Injury, poisoning and procedural complications
ANIMAL BITE
|
0.00%
0/250 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
0.40%
1/250 • Number of events 1 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
0.00%
0/251 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/250 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
0.40%
1/250 • Number of events 1 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
0.00%
0/251 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.00%
0/250 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
0.40%
1/250 • Number of events 1 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
0.00%
0/251 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
0.00%
0/250 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
0.40%
1/250 • Number of events 1 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
0.00%
0/251 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/250 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
0.40%
1/250 • Number of events 1 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
0.00%
0/251 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
Other adverse events
| Measure |
Placebo + ADT
n=250 participants at risk
Cariprazine matching placebo capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.
|
Cariprazine 1.5 mg/Day + ADT
n=250 participants at risk
Cariprazine 1.5 mg capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.
|
Cariprazine 3 mg/Day + ADT
n=251 participants at risk
Cariprazine 1.5 mg capsules, orally, once daily for 2 weeks starting at the Baseline, titrated to 3.0 mg capsules, orally, once daily from Week 2 through Week 6 in addition to their ongoing ADT (same antidepressant and dose of ADT) during the Double-blind Treatment Period, up to Week 6.
|
|---|---|---|---|
|
Gastrointestinal disorders
NAUSEA
|
4.0%
10/250 • Number of events 15 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
5.6%
14/250 • Number of events 16 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
6.4%
16/251 • Number of events 21 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
|
Nervous system disorders
AKATHISIA
|
3.6%
9/250 • Number of events 10 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
7.6%
19/250 • Number of events 19 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
11.6%
29/251 • Number of events 34 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
|
Nervous system disorders
HEADACHE
|
10.8%
27/250 • Number of events 33 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
9.6%
24/250 • Number of events 32 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
10.8%
27/251 • Number of events 40 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
|
Nervous system disorders
SOMNOLENCE
|
4.4%
11/250 • Number of events 11 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
4.8%
12/250 • Number of events 13 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
6.8%
17/251 • Number of events 17 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
|
Psychiatric disorders
INSOMNIA
|
3.6%
9/250 • Number of events 12 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
6.4%
16/250 • Number of events 18 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
10.0%
25/251 • Number of events 29 • First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER