Trial · NCT03033069

A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)

NCT03033069, Phase 2, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2021-12-08

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD). Trials, record NCT03033069. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03033069

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)
NCT number: NCT03033069
Status: Completed
Phases: Phase 2
Enrollment: 336 participants, actual
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions: Stress Disorders, Post-Traumatic
Interventions: Brexpiprazole, Sertraline, Brexpiprazole Matching Placebo, Sertraline Matching Placebo
First posted: 2017-01-26
Last updated: 2021-12-08
Results first posted: 2021-12-08

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Clinician-Administered Post-traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5) Total Score	Baseline, Week 12	CAPS-5:clinician-rated, structured interview to assess PTSD diagnostic status, symptoms severity as defined by DSM-5. CAPS-5 Past Week version of scale was completed at Baseline and at all visits after Baseline. CAPS-5 was calculated by summing severity scores for 20 DSM-5 PTSD symptoms (items 1-20) from categories: Category B:Intrusion symptoms (5 items); Category C:Avoidance symptoms (2 items); Category D:Cognition and mood symptoms (7 items); Category E:Arousal and reactivity symptoms (6 items). CAPS-5 total score was imputed by adding all subscores from categories B,C,D,E. Each symptom was scored 0 (Absent) to 4 (Extreme/incapacitating), to yield a score with range 0-80. Higher scores=worse outcome. Mixed model repeated measure (MMRM) was used for analysis.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Clinician-Administered Post-traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5) Total Score	Baseline, Week 12	ITT Sample included all participants who were randomized in the trial and took at least one dose of double-blind investigational medicinal product (IMP) and have a Baseline and at least one post Baseline evaluation for the CAPS-5 total score. Overall number of participants analyzed are the number of participants with data available for analyses.	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Clinician-Administered Post-traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5) Total Score	Brexpiprazole + Sertraline	-16.4	Standard Error 1.43	score on a scale
Change From Baseline in Clinician-Administered Post-traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5) Total Score	Brexpiprazole	-12.2	Standard Error 1.57	score on a scale
Change From Baseline in Clinician-Administered Post-traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5) Total Score	Sertraline	-11.4	Standard Error 1.46	score on a scale
Change From Baseline in Clinician-Administered Post-traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5) Total Score	Placebo	-10.5	Standard Error 1.40	score on a scale

Source ClinicalTrials.gov

Participant flow20

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Brexpiprazole + Sertraline	82
Overall Study	STARTED	Brexpiprazole	75
Overall Study	STARTED	Sertraline	81
Overall Study	STARTED	Placebo	83
Overall Study	Safety Sample	Brexpiprazole + Sertraline	80
Overall Study	Safety Sample	Brexpiprazole	75
Overall Study	Safety Sample	Sertraline	79
Overall Study	Safety Sample	Placebo	82
Overall Study	Intent to Treat (ITT) Sample	Brexpiprazole + Sertraline	79
Overall Study	Intent to Treat (ITT) Sample	Brexpiprazole	72

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events104

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Constipation	Gastrointestinal disorders	Brexpiprazole + Sertraline	4	80
other	Constipation	Gastrointestinal disorders	Brexpiprazole	2	75
other	Constipation	Gastrointestinal disorders	Sertraline	4	79
other	Constipation	Gastrointestinal disorders	Placebo	4	82
other	Diarrhoea	Gastrointestinal disorders	Brexpiprazole + Sertraline	5	80
other	Diarrhoea	Gastrointestinal disorders	Brexpiprazole	3	75
other	Diarrhoea	Gastrointestinal disorders	Sertraline	7	79
other	Diarrhoea	Gastrointestinal disorders	Placebo	5	82
other	Dry mouth	Gastrointestinal disorders	Brexpiprazole + Sertraline	5	80
other	Dry mouth	Gastrointestinal disorders	Brexpiprazole	6	75

1 to 10 of 104Source ClinicalTrials.gov

See all 104 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Brexpiprazole + Sertraline	0	80
Total, all-cause mortality	Brexpiprazole	0	75
Total, all-cause mortality	Sertraline	0	79
Total, all-cause mortality	Placebo	1	82
Total, other adverse events	Brexpiprazole + Sertraline	47	80
Total, other adverse events	Brexpiprazole	42	75
Total, other adverse events	Sertraline	46	79
Total, other adverse events	Placebo	43	82
Total, serious adverse events	Brexpiprazole + Sertraline	2	80
Total, serious adverse events	Brexpiprazole	1	75

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40009045	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03033069

GET https://conductscience.org/api/trials/v1/NCT03033069/events?page=2

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