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Study of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Pyxis Trial) (Pyxis)

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ClinicalTrials.gov Identifier: NCT01360645
Recruitment Status : Completed
First Posted : May 25, 2011
Results First Posted : November 26, 2015
Last Update Posted : November 26, 2015
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Interventions Drug: OPC-34712 + ADT
Drug: Placebo + ADT
Enrollment 826
Recruitment Details This trial was conducted in 826 subjects at 59 trial sites in the following 5 countries: United States, Canada, Poland, Slovakia, and France.
Pre-assignment Details The study consisted of a 7 to 28-day Screening period, an 8-Week single-blind placebo + ADT prospective Phase-A, a 6-Week double-blind randomization Phase-B or single-blind Phase A+ and a Follow-up of 30 (+2) days after the last dose of study medication.
Arm/Group Title Single-blind Placebo + ADT Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT Phase A+ Placebo + ADT
Hide Arm/Group Description In Phase A, participants were administered placebo as an adjunctive therapy to an open label ADT for 8 weeks Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit. Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit. Participants who did not meet criteria for randomization and a follow-up of 30 (+2) days after the last dose of study medication were in Phase A+
Period Title: Placebo+ADT Prospective Phase-A(8 Weeks)
Started 824 [1] 0 0 0
Completed 710 0 0 0
Not Completed 114 0 0 0
Reason Not Completed
Lost to Follow-up             16             0             0             0
Adverse Event             19             0             0             0
Met Withdrawal Criteria             16             0             0             0
Withdrawal by Subject             34             0             0             0
Protocol Deviation             24             0             0             0
Physician Decision             5             0             0             0
[1]
826 participants were enrolled but 2 participants discontinued trial before taking study medication.
Period Title: Phase B (6 Weeks)
Started 0 188 191 0
Completed 0 174 178 0
Not Completed 0 14 13 0
Reason Not Completed
Lost to Follow-up             0             1             0             0
Adverse Event             0             6             0             0
Met Withdrawal Criteria             0             3             2             0
Withdrawal by Subject             0             3             8             0
Protocol Deviation             0             1             3             0
Period Title: Phase A+
Started 0 0 0 331
Completed 0 0 0 307
Not Completed 0 0 0 24
Reason Not Completed
Lost to Follow-up             0             0             0             7
Adverse Event             0             0             0             2
Met Withdrawal Criteria             0             0             0             4
Physician Decision             0             0             0             2
Withdrawal by Subject             0             0             0             5
Protocol Deviation             0             0             0             4
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT Total
Hide Arm/Group Description Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit. Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit. Total of all reporting groups
Overall Number of Baseline Participants 188 191 379
Hide Baseline Analysis Population Description
Randomized sample were used. Randomized sample comprises all who were randomized in Phase B.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 188 participants 191 participants 379 participants
44.1  (11.6) 45.2  (11.3) 44.6  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 188 participants 191 participants 379 participants
Female
130
  69.1%
137
  71.7%
267
  70.4%
Male
58
  30.9%
54
  28.3%
112
  29.6%
1.Primary Outcome
Title Change From Baseline (End of Phase A [Week 8]) to Week 14 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score for the Efficacy Sample.
Hide Description The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place.
Time Frame Baseline and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 187 191
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-8.27  (0.61) -5.15  (0.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments The primary analysis was performed on the Efficacy Sample by fitting a Mixed Model Repeated Measures (MMRM) analysis with an unstructured variance covariance structure in which the change from the end of Phase A (Week 8) in MADRS Total Score (at Weeks 9 to 14) was the dependent variable. The model included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.12
Confidence Interval (2-Sided) 95%
-4.70 to -1.54
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score for the Efficacy Sample Per the Final Protocol.
Hide Description The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place.
Time Frame Baseline and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 175 178
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-8.36  (0.64) -5.15  (0.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.21
Confidence Interval (2-Sided) 95%
-4.87 to -1.54
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Change From Baseline (End of Phase A [Week 8]) to Week 14 in Sheehan Disability Scale (SDS) Score for the Efficacy Sample.
Hide Description The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.
Time Frame Baseline and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 179 181
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.35  (0.17) -0.91  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0372
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.45
Confidence Interval (2-Sided) 95%
-0.86 to -0.03
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Change From Baseline (End of Phase A [Week 8]) to Week 14 in SDS Score for the Efficacy Sample Per the Final Protocol
Hide Description The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.
Time Frame Baseline and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 167 170
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.35  (0.17) -0.89  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0349
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-0.88 to -0.03
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score by Trial Week for the Efficacy Sample.
Hide Description The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place.
Time Frame Week 9, 10, 11, 12, and 13
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 187 191
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 9 -3.15  (0.40) -1.86  (0.39)
Week 10 -5.15  (0.47) -3.43  (0.47)
Week 11 -6.69  (0.52) -4.06  (0.52)
Week 12 -7.22  (0.55) -4.63  (0.54)
Week 13 -8.28  (0.58) -5.10  (0.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0080
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.29
Confidence Interval (2-Sided) 95%
-2.25 to -0.34
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0045
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.72
Confidence Interval (2-Sided) 95%
-2.91 to -0.54
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 11
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.63
Confidence Interval (2-Sided) 95%
-3.96 to -1.30
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.59
Confidence Interval (2-Sided) 95%
-4.01 to -1.18
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0000
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.19
Confidence Interval (2-Sided) 95%
-4.68 to -1.70
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score by Trial Week for the Efficacy Sample Per the Final Protocol.
Hide Description The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place.
Time Frame Week 9, 10, 11, 12, and 13
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 175 178
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 9 -3.05  (0.41) -1.74  (0.41)
Week 10 -5.04  (0.49) -3.52  (0.48)
Week 11 -6.58  (0.54) -4.17  (0.53)
Week 12 -7.24  (0.58) -4.72  (0.57)
Week 13 -8.28  (0.61) -5.01  (0.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0086
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.31
Confidence Interval (2-Sided) 95%
-2.28 to -0.34
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0149
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.52
Confidence Interval (2-Sided) 95%
-2.74 to -0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 11
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.42
Confidence Interval (2-Sided) 95%
-3.78 to -1.05
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.52
Confidence Interval (2-Sided) 95%
-4.00 to -1.04
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0000
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.28
Confidence Interval (2-Sided) 95%
-4.84 to -3.28
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Mean Clinical Global Impression-Improvement (CGI-I) Scale Score (End of Phase A [Week 8]) to Week 14 by Trial Week for the Efficacy Sample.
Hide Description The items on CGI-I scale are: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) will be set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. The CGI-I was measured in related to Baseline (Week 8).
Time Frame Week 9, 10, 11, 12, 13, and 14
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 187 191
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 9 3.41  (0.83) 3.62  (0.74)
Week 10 3.17  (0.89) 3.37  (0.82)
Week 11 3.03  (1.02) 3.23  (0.90)
Week 12 2.84  (0.99) 3.19  (1.04)
Week 13 2.74  (1.07) 3.13  (1.06)
Week 14 2.75  (1.13) 3.13  (1.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0022
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value and treatment difference (CI) are derived from Cochran-Mantel-Haenszel (CMH) row mean score differ test controlling for study center.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.38 to -0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0115
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.38 to -0.05
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 11
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0255
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.41 to -0.03
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-0.57 to -0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-0.62 to -0.20
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-0.60 to -0.17
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Mean CGI-I Scale Score (End of Phase A [Week 8]) to Week 14 by Trial Week for the Efficacy Sample Per the Final Protocol.
Hide Description The items on CGI-I scale are: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) will be set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. The CGI-I was measured in related to Baseline (Week 8).
Time Frame Week 9, 10, 11, 12, 13, and 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 175 178
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 9 3.44  (0.81) 3.67  (0.70)
Week 10 3.21  (0.89) 3.40  (0.82)
Week 11 3.07  (1.01) 3.25  (0.89)
Week 12 2.85  (1.01) 3.23  (1.05)
Week 13 2.78  (1.07) 3.18  (1.06)
Week 14 2.77  (1.14) 3.17  (1.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-0.40 to -0.10
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0290
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.37 to -0.02
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 11
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0422
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.40 to -0.01
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-0.61 to -0.18
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-0.64 to -0.20
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-0.65 to -0.19
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline (End of Phase A [Week 8]) to Week 14 in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score for the Efficacy Sample.
Hide Description Items on CGI-S scale are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) will be set to missing. The CGI-S is therefore a 7-point scale from 1 through 7.
Time Frame Week 9, 10, 11, 12, 13, and 14
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 187 191
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 9 -0.25  (0.05) -0.12  (0.05)
Week 10 -0.45  (0.05) -0.31  (0.05)
Week 11 -0.61  (0.06) -0.40  (0.06)
Week 12 -0.70  (0.07) -0.45  (0.06)
Week 13 -0.86  (0.07) -0.50  (0.07)
Week 14 -0.91  (0.07) -0.58  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0229
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.25 to -0.02
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0459
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.28 to -0.00
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 11
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0097
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-0.37 to -0.05
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0038
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-0.42 to -0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-0.54 to -0.18
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 14.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.52 to -0.15
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline (End of Phase A [Week 8]) to Week 14 in CGI-S Scale Score for the Efficacy Sample Per the Final Protocol.
Hide Description Items on CGI-S scale are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) will be set to missing. The CGI-S is therefore a 7-point scale from 1 through 7.
Time Frame Week 9, 10, 11, 12, 13, and 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 175 178
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 9 -0.24  (0.05) -0.09  (0.05)
Week 10 -0.43  (0.06) -0.32  (0.06)
Week 11 -0.58  (0.06) -0.42  (0.06)
Week 12 -0.70  (0.07) -0.46  (0.07)
Week 13 -0.85  (0.07) -0.50  (0.07)
Week 14 -0.91  (0.07) -0.57  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0109
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.27 to -0.04
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1286
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.25 to 0.03
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 11
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0521
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.16
Confidence Interval (2-Sided) 95%
-0.32 to 0.00
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0084
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.42 to -0.06
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-0.54 to -0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.53 to -0.15
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline (End of Phase A [Week 8]) to Week 14 in the Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score for the Efficacy Sample.
Hide Description

The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the “best” rating and 3 being the “worst” rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. Should items 11 and 12 be rated both, then the maximum of the two scores will be used. The same approach will be used for handling items 13 and 14.

The IDS-SR total score is the sum of ratings of 28 item scores. The possible IDS-SR total score ranges from 0 to 84.

Time Frame Week 9, 10, 11, 12, 13, and 14
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 187 191
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 9 -3.02  (0.52) -1.45  (0.51)
Week 10 -4.17  (0.59) -2.64  (0.59)
Week 11 -5.41  (0.65) -4.31  (0.64)
Week 12 -6.16  (0.68) -4.69  (0.67)
Week 13 -7.00  (0.72) -5.25  (0.71)
Week 14 -7.49  (0.74) -5.52  (0.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0139
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.57
Confidence Interval (2-Sided) 95%
-2.82 to -0.32
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0436
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.53
Confidence Interval (2-Sided) 95%
-3.01 to -0.04
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 11
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1903
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.10
Confidence Interval (2-Sided) 95%
-2.75 to 0.55
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0951
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.47
Confidence Interval (2-Sided) 95%
-3.21 to 0.26
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0626
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.75
Confidence Interval (2-Sided) 95%
-3.59 to 0.09
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0435
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.96
Confidence Interval (2-Sided) 95%
-3.87 to -0.06
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline (End of Phase A [Week 8]) to Week 14 in the IDS-SR Total Score for the Efficacy Sample Per the Final Protocol.
Hide Description

The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the “best” rating and 3 being the “worst” rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. Should items 11 and 12 be rated both, then the maximum of the two scores will be used. The same approach will be used for handling items 13 and 14.

The IDS-SR total score is the sum of ratings of 28 item scores. The possible IDS-SR total score ranges from 0 to 84.

Time Frame Week 9, 10, 11, 12, 13, and 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 175 178
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 9 -3.30  (0.53) -1.59  (0.51)
Week 10 -4.29  (0.61) -3.13  (0.60)
Week 11 -5.45  (0.67) -4.73  (0.66)
Week 12 -6.32  (0.71) -5.06  (0.70)
Week 13 -7.03  (0.74) -5.60  (0.73)
Week 14 -7.59  (0.77) -6.05  (0.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0069
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.71
Confidence Interval (2-Sided) 95%
-2.95 to -0.47
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1322
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.16
Confidence Interval (2-Sided) 95%
-2.68 to 0.35
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 11
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4055
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.72
Confidence Interval (2-Sided) 95%
-2.41 to 0.98
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1715
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.26
Confidence Interval (2-Sided) 95%
-3.08 to 0.55
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1424
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.42
Confidence Interval (2-Sided) 95%
-3.33 to 0.48
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Week 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1270
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.54
Confidence Interval (2-Sided) 95%
-3.52 to 0.44
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample.
Hide Description The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.
Time Frame Week 11 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 187 191
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Item: Work/School: Week 11 -0.70  (0.21) -0.42  (0.22)
Item: Work/School: Week 14 -1.09  (0.22) -0.90  (0.22)
Item: Social life: Week 11 -1.17  (0.17) -0.67  (0.17)
Item: Social life: Week 14 -1.54  (0.19) -1.04  (0.18)
Item: Family life: Week 11 -1.06  (0.18) -0.43  (0.18)
Item: Family life: Week 14 -1.33  (0.19) -0.73  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments For Item: Work/School: Week 11
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3079
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.81 to 0.26
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments For Item: Work/School: Week 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4771
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.73 to 0.34
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments For Item: Social life: Week 11
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0195
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.50
Confidence Interval (2-Sided) 95%
-0.92 to -0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments For Item: Social life: Week 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0323
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.50
Confidence Interval (2-Sided) 95%
-0.96 to -0.04
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments For Item: Family life: Week 11
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0058
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.63
Confidence Interval (2-Sided) 95%
-1.07 to -0.18
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments For Item: Family life: Week 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0129
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.60
Confidence Interval (2-Sided) 95%
-1.07 to -0.13
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Per the Final Protocol.
Hide Description The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.
Time Frame Week 11 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 175 178
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Item: Work/School: Week 11 -0.76  (0.22) -0.58  (0.22)
Item: Work/School: Week 14 -1.11  (0.23) -0.96  (0.23)
Item: Social life: Week 11 -1.18  (0.18) -0.69  (0.18)
Item: Social life: Week 14 -1.57  (0.19) -1.02  (0.19)
Item: Family life: Week 11 -0.99  (0.19) -0.43  (0.18)
Item: Family life: Week 14 -0.43  (0.18) -0.70  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Item: Work/School Week 11
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5151
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.71 to 0.36
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Item: Work/School Week 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6080
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.70 to 0.41
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Item: Social life-Week 11
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0267
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-0.92 to -0.06
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Item: Social life-Week 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0224
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-1.01 to -0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Item: Family life-Week 11
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0146
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.56
Confidence Interval (2-Sided) 95%
-1.01 to -0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments Statistical analysis for Item: Family life-Week 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0113
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-1.09 to -0.14
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline (End of Phase A [Week 8]) to Week 14 in Hamilton Depression (HAM-D) Rating Scale Total Score for the Efficacy Sample.
Hide Description The HAM-D (17-Item) consists of 17 items. Eight items are rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) are rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 is the “best” rating and the highest score (2 or 4) is the “worst” rating. The sum of the scores from the first 17 items; 0-7 =Normal; 8-13 =mild depression; 14-18 =moderate depression; 19-22 =severe depression; ≥23 =very severe depression. The total score ranges from 0 to 52, with higher score indicating worse depressive symptoms.
Time Frame Baseline and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Sample comprised all participants in Safety Sample who had end of Phase A value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The Last-observation-carried-forward (LOCF) data set included data recorded at Phase B visit, if no observation was recorded, data was carried forward from previous visit.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 183 188
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-5.89  (0.48) -3.55  (0.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments ANCOVA_Last observation carry forward (LOCF) model with treatment and trial site as main effects, and baseline (end of Phase A [Week 8]) value as a covariate was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.34
Confidence Interval (2-Sided) 95%
-3.47 to -1.22
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline (End of Phase A [Week 8]) to Week 14 in HAM-D Rating Scale Total Score for the Efficacy Sample Per the Final Protocol.
Hide Description The HAM-D (17-Item) consists of 17 items. Eight items are rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) are rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 is the “best” rating and the highest score (2 or 4) is the “worst” rating. The sum of the scores from the first 17 items; 0-7 =Normal; 8-13 =mild depression; 14-18 =moderate depression; 19-22 =severe depression; ≥23 =very severe depression. The total score ranges from 0 to 52, with higher score indicating worse depressive symptoms.
Time Frame Baseline and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at Phase B visit, if no observation was recorded, data was carried forward from previous visit.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 172 175
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-5.89  (0.51) -3.59  (0.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.29
Confidence Interval (2-Sided) 95%
-3.47 to -1.12
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline (End of Phase A [Week 8]) to Week 14 in Hamilton Anxiety (HAM-A) Rating Scale Total Score for the Efficacy Sample
Hide Description The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the “best” rating and 4 is the “worst” rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher scores indicating worse anxiety symptoms.
Time Frame Baseline and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 181 188
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-3.94  (0.43) -2.77  (0.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments ANCOVA_LOCF model with treatment and trial site as main effects, and baseline (end of Phase A [Week 8]) value as a covariate was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0219
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.17
Confidence Interval (2-Sided) 95%
-2.17 to -0.17
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline (End of Phase A [Week 8]) to Week 14 in HAM-A Rating Scale Total Score for the Efficacy Sample Per the Final Protocol.
Hide Description The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the “best” rating and 4 is the “worst” rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher scores indicating worse anxiety symptoms.
Time Frame Baseline and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 171 175
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-3.79  (0.45) -2.70  (0.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0376
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.09
Confidence Interval (2-Sided) 95%
-2.13 to -0.06
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Percentage of Participants With MADRS Response at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample.
Hide Description The MADRS response was defined as >/=50% reduction in MADRS total score from end of Phase A (Week 8).
Time Frame Baseline and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 187 191
Measure Type: Number
Unit of Measure: Percentage of participants
23.5 14.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0176
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CHM general association test controlling for trial site.
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.63
Confidence Interval (2-Sided) 95%
1.09 to 2.44
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Percentage of Participants With MADRS Response at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample Per the Final Protocol.
Hide Description The MADRS response was defined as >/=50% reduction in MADRS total score from end of Phase A (Week 8).
Time Frame Baseline and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 175 178
Measure Type: Number
Unit of Measure: Percentage of participants
23.4 15.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0429
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CHM general association test controlling for trial site.
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.54
Confidence Interval (2-Sided) 95%
1.01 to 2.35
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Percentage of Participants With MADRS Remission at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample.
Hide Description MADRS remission was defined as </=10 and >/=50% reduction in MADRS total score from end of Phase A (Week 8).
Time Frame Baseline and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 187 191
Measure Type: Number
Unit of Measure: Percentage of participants
14.4 8.38
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0586
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CHM general association test controlling for trial site.
Method of Estimation Estimation Parameter Ratio of Remission Rate
Estimated Value 1.68
Confidence Interval (2-Sided) 95%
0.98 to 2.86
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Percentage of Participants With MADRS Remission at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample Per the Final Protocol.
Hide Description MADRS remission was defined as </=10 and >/=50% reduction in MADRS total score from end of Phase A (Week 8).
Time Frame Baseline and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 175 178
Measure Type: Number
Unit of Measure: Percentage of participants
14.9 8.99
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0671
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CHM general association test controlling for trial site.
Method of Estimation Estimation Parameter Ratio of Remission Rate
Estimated Value 1.67
Confidence Interval (2-Sided) 95%
0.97 to 2.90
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Percentage of Participants With CGI-I Scale Response Rate at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample.
Hide Description CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).
Time Frame Baseline and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 187 191
Measure Type: Number
Unit of Measure: Percentage of participants
44.4 27.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CHM general association test controlling for trial site.
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.61
Confidence Interval (2-Sided) 95%
1.23 to 2.10
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Percentage of Participants With CGI-I Scale Response Rate at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample Per the Final Protocol.
Hide Description CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).
Time Frame Baseline and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description:
Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
Overall Number of Participants Analyzed 175 178
Measure Type: Number
Unit of Measure: Percentage of participants
43.4 26.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brexpiprazole 2 mg/Day + ADT, Double-blind Placebo + ADT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CHM general association test controlling for trial site.
Method of Estimation Estimation Parameter Ratio of Response Rate
Estimated Value 1.69
Confidence Interval (2-Sided) 95%
1.27 to 2.27
Estimation Comments [Not Specified]
Time Frame Adverse Events with an onset date on or after the start of double-blind treatment and occurring up to 30 days after the last day of double-blind treatment were included.
Adverse Event Reporting Description Safety sample comprised of randomized participants in Phase B who received at least one dose of double-blind trial medication. Participants were excluded only if there was evidence that the participant did not take trial medication. If a participant was dispensed trial medication and is lost to follow-up that participant was considered exposed.
 
Arm/Group Title Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Hide Arm/Group Description Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit. Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
All-Cause Mortality
Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Affected / at Risk (%) Affected / at Risk (%)
Total   2/188 (1.06%)   2/191 (1.05%) 
Cardiac disorders     
Atrial Fibrillation * 1  0/188 (0.00%)  1/191 (0.52%) 
Gastrointestinal disorders     
Abdominal Pain * 1  1/188 (0.53%)  0/191 (0.00%) 
Infections and infestations     
Pneumonia * 1  0/188 (0.00%)  1/191 (0.52%) 
Injury, poisoning and procedural complications     
Comminuted Fracture * 1  1/188 (0.53%)  0/191 (0.00%) 
Nervous system disorders     
Syncope * 1  1/188 (0.53%)  0/191 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brexpiprazole 2 mg/Day + ADT Double-blind Placebo + ADT
Affected / at Risk (%) Affected / at Risk (%)
Total   37/188 (19.68%)   27/191 (14.14%) 
Gastrointestinal disorders     
Diarrhoea * 1  5/188 (2.66%)  10/191 (5.24%) 
Infections and infestations     
Upper resporatory tract infection * 1  6/188 (3.19%)  12/191 (6.28%) 
Investigations     
Weight increased * 1  15/188 (7.98%)  6/191 (3.14%) 
Nervous system disorders     
Akathisia * 1  14/188 (7.45%)  2/191 (1.05%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development & Commercialization, Inc
Phone: 800 562-3974
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01360645     History of Changes
Other Study ID Numbers: 331-10-228
First Submitted: May 24, 2011
First Posted: May 25, 2011
Results First Submitted: August 10, 2015
Results First Posted: November 26, 2015
Last Update Posted: November 26, 2015