Trial · NCT04124614
Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD
NCT04124614, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2025-06-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD. Trials, record NCT04124614. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04124614
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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 Treatment of Adults With PTSD
- NCT number
- NCT04124614
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 450 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Post Traumatic Stress Disorder
- Interventions
- Brexpiprazole, Sertraline, Placebo
- First posted
- 2019-10-11
- Last updated
- 2025-06-13
- Results first posted
- 2025-06-13
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 is a structured interview designed to assess PTSD diagnostic status \& 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 following categories: Category B: Intrusion symptoms (5 items); Category C: Avoidance symptoms (2 items); Category D: Cognition \& mood symptoms (7 items); Category E: Arousal \& 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, yielding 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 class effect terms for treatment, trial site, visit, previous treatment intervention for PTSD (Yes/No), \& an interaction term of treatment by visit, \& include the interaction term of baseline values of CAPS-5 total score by visit 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 it, 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 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 class effect terms for treatment, trial site, visit, previous treatment intervention for PTSD (Yes/No), \& an interaction term of treatment by visit, \& include the interaction term of baseline values of CAPS-5 total score by visit as a covariate. |
| Secondary | Change in Brief Inventory or Psychosocial Functions (B-IPF) Score | Baseline (Day 1), 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. It 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 class effect terms for treatment, trial site, visit, previous treatment intervention for PTSD (Yes/No), \& an interaction term of treatment by visit, \& include the interaction term of baseline values of CAPS-5 total score by visit 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 or Psychosocial Functions (B-IPF) Score | Baseline (Day 1), 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 group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Score | Brexpiprazole + Sertraline | -19.19 | Standard Error 1.17 | score on a scale | |
| Change From Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Score | Sertraline + Placebo | -13.61 | Standard Error 1.24 | score on a scale | |
| Change in Clinical Global Impression - Severity (CGI-S) Score | Brexpiprazole + Sertraline | -1.54 | Standard Error 0.10 | score on a scale | |
| Change in Clinical Global Impression - Severity (CGI-S) Score | Sertraline + Placebo | -1.08 | Standard Error 0.11 | score on a scale | |
| Change in Brief Inventory or Psychosocial Functions (B-IPF) Score | Brexpiprazole + Sertraline | -33.80 | Standard Error 2.84 | score on a scale | |
| Change in Brief Inventory or Psychosocial Functions (B-IPF) Score | Sertraline + Placebo | -21.77 | Standard Error 2.97 | score on a scale |
Source ClinicalTrials.gov
Participant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Placebo Run-in Period | STARTED | Placebo | 450 | |
| Placebo Run-in Period | STARTED | Brexpiprazole + Sertraline | 0 | |
| Placebo Run-in Period | STARTED | Sertraline + Placebo | 0 | |
| Placebo Run-in Period | COMPLETED | Placebo | 416 | |
| Placebo Run-in Period | COMPLETED | Brexpiprazole + Sertraline | 0 | |
| Placebo Run-in Period | COMPLETED | Sertraline + Placebo | 0 | |
| Placebo Run-in Period | NOT COMPLETED | Placebo | 34 | |
| Placebo Run-in Period | NOT COMPLETED | Brexpiprazole + Sertraline | 0 | |
| Placebo Run-in Period | NOT COMPLETED | Sertraline + Placebo | 0 | |
| Double Blind Treatment Period | STARTED | Placebo | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events24
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 | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Brexpiprazole + Sertraline | 9 | 205 | |
| other | Diarrhoea | Gastrointestinal disorders | Sertraline + Placebo | 13 | 196 | |
| other | Nausea | Gastrointestinal disorders | Brexpiprazole + Sertraline | 25 | 205 | |
| other | Nausea | Gastrointestinal disorders | Sertraline + Placebo | 23 | 196 | |
| other | Fatigue | General disorders | Brexpiprazole + Sertraline | 14 | 205 | |
| other | Fatigue | General disorders | Sertraline + Placebo | 8 | 196 | |
| other | Weight Increased | Investigations | Brexpiprazole + Sertraline | 12 | 205 | |
| other | Weight Increased | Investigations | Sertraline + Placebo | 3 | 196 | |
| other | Headache | Nervous system disorders | Brexpiprazole + Sertraline | 10 | 205 | |
| other | Headache | Nervous system disorders | Sertraline + Placebo | 17 | 196 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brexpiprazole + Sertraline | 0 | 205 |
| Total, all-cause mortality | Sertraline + Placebo | 1 | 196 |
| Total, other adverse events | Brexpiprazole + Sertraline | 68 | 205 |
| Total, other adverse events | Sertraline + Placebo | 58 | 196 |
| Total, serious adverse events | Brexpiprazole + Sertraline | 1 | 205 |
| Total, serious adverse events | Sertraline + Placebo | 4 | 196 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39693081 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Brexpiprazole + Sertraline vs Sertraline + Placebo: deaths from any cause | Trial comparisons |
| Brexpiprazole + Sertraline vs Sertraline + Placebo: serious adverse events | Trial comparisons |
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.
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/NCT04124614
GET https://conductscience.org/api/trials/v1/NCT04124614/flow?page=2