Trial · NCT04174170

Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder

NCT04174170, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2025-05-30

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder. Trials, record NCT04174170. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04174170

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Trial

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

Title: Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder
NCT number: NCT04174170
Status: Completed
Phases: Phase 3
Enrollment: 591 participants, actual
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions: Post Traumatic Stress Disorder
Interventions: Brexpiprazole, Sertraline, Placebo, Brexpiprazole
First posted: 2019-11-22
Last updated: 2025-05-30
Results first posted: 2025-05-30

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Score	Baseline (Week 1), Week 10	CAPS-5 was a structured interview designed to assess PTSD diagnostic status and symptoms severity as defined by DSM-5. CAPS -5 total score 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 range of 0-80. Higher scores indicate worse outcome. Least squares (LS) mean was determined by Mixed-effect model repeated measures (MMRM) method with fixed effect of treatment, trial site, visit week, and an interaction term of treatment by visit week, and included the interaction term of baseline values by visit week as a covariate.
Secondary	Change in Clinical Global Impression - Severity (CGI-S) Score	Baseline (Week 1), Week 10	The CGI-S is a standardized, clinician-administered global rating scale that measures disease severity. To assess CGI-S, the rater or investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. The score 0 (not assessed) was to be set to missing. The CGI-S is therefore a 7-point scale from 1 through 7. A higher score on the CGI-S represents a higher severity of disease. LS mean was determined by MMRM method with fixed effect of treatment, trial site, visit week, and an interaction term of treatment by visit week, and included the interaction term of baseline values by visit week as a covariate.
Secondary	Change in Brief Inventory of Psychosocial Functions (B-IPF) Score	Baseline, Week 12	The B-IPF is a short patient-reported questionnaire consisting of 7 questions which measure PTSD-specific psychosocial function on a 7-point Likert scale (0 = not at all to 6 = very much, and a not applicable option) with a recall period of 30 days. The B-IPF measures the concepts of romantic relationships, parenting, family, friendships and socializing, work, education, and self-care. Total score ranges from 0-100 and is calculated by summing the completed scale items, dividing by the maximum possible score of all items and multiplying by 100. Higher scores indicate greater impairment. LS mean was determined by MMRM method with fixed effect of treatment, trial site, visit week, and an interaction term of treatment by visit week, and included the interaction term of baseline values by visit week as a covariate.

Source ClinicalTrials.gov

Outcomes3

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 PTSD Scale for DSM-5 (CAPS-5) Total Score	Baseline (Week 1), Week 10	FAS for Enriched participants included those participants in the Enriched Randomized Sample who received at least 1 dose of double-blind IMP, had a baseline value (Week 1) and at least 1 post baseline efficacy evaluation for CAPS-5 total score. Overall number analyzed is the number of participants with data available for analysis.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Clinical Global Impression - Severity (CGI-S) Score	Baseline (Week 1), Week 10	FAS for Enriched participants included those participants in the Enriched Randomized Sample who received at least 1 dose of double-blind IMP, had a baseline value (Week 1) and at least 1 post baseline efficacy evaluation for CAPS-5 total score. Overall number of participants analyzed is the number of participants with data available for analysis.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Brief Inventory of Psychosocial Functions (B-IPF) Score	Baseline, Week 12	FAS for Enriched participants included those participants in the Enriched Randomized Sample who received at least 1 dose of double-blind IMP, had a baseline value (Week 1) and at least 1 post baseline efficacy evaluation for CAPS-5 total score. Overall number of participants analyzed is the number of participants with data available for analysis.	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group9

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 PTSD Scale for DSM-5 (CAPS-5) Total Score	Brexpiprazole (2 mg) + Sertraline	-16.53	Standard Error 1.19	score on a scale
Change From Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Score	Brexpiprazole (3 mg) + Sertraline	-18.28	Standard Error 1.23	score on a scale
Change From Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Score	Sertraline + Placebo	-17.57	Standard Error 1.19	score on a scale
Change in Clinical Global Impression - Severity (CGI-S) Score	Brexpiprazole (2 mg) + Sertraline	-1.26	Standard Error 0.10	score on a scale
Change in Clinical Global Impression - Severity (CGI-S) Score	Brexpiprazole (3 mg) + Sertraline	-1.31	Standard Error 0.11	score on a scale
Change in Clinical Global Impression - Severity (CGI-S) Score	Sertraline + Placebo	-1.29	Standard Error 0.10	score on a scale
Change in Brief Inventory of Psychosocial Functions (B-IPF) Score	Brexpiprazole (2 mg) + Sertraline	-27.12	Standard Error 2.67	score on a scale
Change in Brief Inventory of Psychosocial Functions (B-IPF) Score	Brexpiprazole (3 mg) + Sertraline	-31.79	Standard Error 2.86	score on a scale
Change in Brief Inventory of Psychosocial Functions (B-IPF) Score	Sertraline + Placebo	-22.96	Standard Error 2.71	score on a scale

Source ClinicalTrials.gov

Participant flow40

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

Period	Milestone	Group	Participants
Placebo Run-in Period	STARTED	Placebo	591
Placebo Run-in Period	STARTED	Brexpiprazole (2 mg) + Sertraline	0
Placebo Run-in Period	STARTED	Brexpiprazole (3 mg) + Sertraline	0
Placebo Run-in Period	STARTED	Sertraline + Placebo	0
Placebo Run-in Period	COMPLETED	Placebo	553
Placebo Run-in Period	COMPLETED	Brexpiprazole (2 mg) + Sertraline	0
Placebo Run-in Period	COMPLETED	Brexpiprazole (3 mg) + Sertraline	0
Placebo Run-in Period	COMPLETED	Sertraline + Placebo	0
Placebo Run-in Period	NOT COMPLETED	Placebo	38
Placebo Run-in Period	NOT COMPLETED	Brexpiprazole (2 mg) + Sertraline	0

1 to 10 of 40Source ClinicalTrials.gov

See all 40 participant flow

Adverse events27

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	Diarrhoea	Gastrointestinal disorders	Brexpiprazole (2 mg) + Sertraline	7	185
other	Diarrhoea	Gastrointestinal disorders	Brexpiprazole (3 mg) + Sertraline	11	180
other	Diarrhoea	Gastrointestinal disorders	Sertraline + Placebo	11	172
other	Nausea	Gastrointestinal disorders	Brexpiprazole (2 mg) + Sertraline	9	185
other	Nausea	Gastrointestinal disorders	Brexpiprazole (3 mg) + Sertraline	15	180
other	Nausea	Gastrointestinal disorders	Sertraline + Placebo	15	172
other	Headache	Nervous system disorders	Brexpiprazole (2 mg) + Sertraline	13	185
other	Headache	Nervous system disorders	Brexpiprazole (3 mg) + Sertraline	10	180
other	Headache	Nervous system disorders	Sertraline + Placebo	13	172
other	Insomnia	Psychiatric disorders	Brexpiprazole (2 mg) + Sertraline	7	185

1 to 10 of 27Source ClinicalTrials.gov

See all 27 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Brexpiprazole (2 mg) + Sertraline	1	185
Total, all-cause mortality	Brexpiprazole (3 mg) + Sertraline	0	180
Total, all-cause mortality	Sertraline + Placebo	0	172
Total, other adverse events	Brexpiprazole (2 mg) + Sertraline	31	185
Total, other adverse events	Brexpiprazole (3 mg) + Sertraline	35	180
Total, other adverse events	Sertraline + Placebo	36	172
Total, serious adverse events	Brexpiprazole (2 mg) + Sertraline	1	185
Total, serious adverse events	Brexpiprazole (3 mg) + Sertraline	1	180
Total, serious adverse events	Sertraline + Placebo	3	172

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40982703	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.

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Read this trial from software.

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

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