A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)
A Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial of Brexpiprazole (1 - 3 mg/Day) as Monotherapy or as Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder
1 other identifier
interventional
336
1 country
54
Brief Summary
To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as monotherapy or combination therapy with Zoloft (sertraline) in adults with PTSD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2017
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2017
CompletedFirst Posted
Study publicly available on registry
January 26, 2017
CompletedStudy Start
First participant enrolled
January 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2018
CompletedResults Posted
Study results publicly available
December 8, 2021
CompletedDecember 8, 2021
November 1, 2021
1.8 years
January 24, 2017
October 8, 2021
November 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
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.
Baseline, Week 12
Study Arms (4)
Brexpiprazole + Sertraline
EXPERIMENTALParticipants were administered oral brexpiprazole initial dose of 0.5 milligram (mg)/day plus sertraline initial dose of 50 mg/day. The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo based on dose titration/adjustment up to Week 12.
Brexpiprazole
EXPERIMENTALParticipants were administered oral brexpiprazole initial dose of 0.5 mg/day The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo up to Week 12.
Sertraline
ACTIVE COMPARATORParticipants were administered oral sertraline initial dose of 50 mg/day. The dose was up titrated to sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received brexpiprazole matching placebo and sertraline matching placebo based on dose titration/adjustment up to Week 12.
Placebo
PLACEBO COMPARATORParticipants received oral brexpiprazole matching placebo tablet and oral sertraline matching placebo capsules up to Week 12.
Interventions
Brexpiprazole oral tablets.
Sertraline matching placebo oral capsules.
Eligibility Criteria
You may qualify if:
- Male and female participants between the years of 18-65 with a diagnosis of PTSD (diagnosis can be made at screening)
You may not qualify if:
- Index trauma event \>15 years before screening
- Index trauma event at age \<16
- Any traumatic event within 3 months of screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Investigational Site
Tuscaloosa, Alabama, 35404, United States
Investigational Site
Phoenix, Arizona, 85032, United States
Investigational Site
Little Rock, Arkansas, 72211, United States
Investigational Site
Rogers, Arkansas, 72758, United States
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Bellflower, California, 90706, United States
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Beverly Hills, California, 90210, United States
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Glendale, California, 91206, United States
Investigational Site
National City, California, 91950, United States
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Oceanside, California, 92054, United States
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Oceanside, California, 92056, United States
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Orange, California, 92868, United States
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Redlands, California, 92374, United States
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Riverside, California, 92506, United States
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San Diego, California, 92103, United States
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San Marcos, California, 92078, United States
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Torrance, California, 90502, United States
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Colorado Springs, Colorado, 80910, United States
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Bradenton, Florida, 34201, United States
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Fort Lauderdale, Florida, 33319, United States
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Fort Myers, Florida, 33912, United States
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Gainesville, Florida, 32607, United States
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Jacksonville, Florida, 32256, United States
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North Miami, Florida, 33161, United States
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Orlando, Florida, 32801, United States
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Orlando, Florida, 32806, United States
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Tampa, Florida, 33614, United States
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Atlanta, Georgia, 30341, United States
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Decatur, Georgia, 30030, United States
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Roswell, Georgia, 30076, United States
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Chicago, Illinois, 60640, United States
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St Louis, Missouri, 63141, United States
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Las Vegas, Nevada, 89102, United States
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Berlin, New Jersey, 08009, United States
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Princeton, New Jersey, 08540, United States
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Brooklyn, New York, 11235, United States
Investigational Site
Cedarhurst, New York, 11516, United States
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New York, New York, 10128, United States
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Rochester, New York, 14618, United States
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Charlotte, North Carolina, 28211, United States
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Raleigh, North Carolina, 27609, United States
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Cincinnati, Ohio, 45215, United States
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Oklahoma City, Oklahoma, 73103, United States
Investigational Site
Oklahoma City, Oklahoma, 73118, United States
Investigational Site
Portland, Oregon, 97214, United States
Investigational Site
Salem, Oregon, 97301, United States
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Media, Pennsylvania, 19063, United States
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Norristown, Pennsylvania, 19403, United States
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Lincoln, Rhode Island, 02865, United States
Investigational Site
Charleston, South Carolina, 29401, United States
Investigational Site
Memphis, Tennessee, 38119, United States
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Bellaire, Texas, 77401, United States
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San Antonio, Texas, 78229, United States
Investigational Site
Wichita Falls, Texas, 76309, United States
Investigational Site
Everett, Washington, 98201, United States
Related Publications (1)
Hobart M, Chang D, Hefting N, Davis LL. Brexpiprazole in Combination With Sertraline and as Monotherapy in Posttraumatic Stress Disorder: A Full-Factorial Randomized Clinical Trial. J Clin Psychiatry. 2025 Feb 19;86(1):24m15577. doi: 10.4088/JCP.24m15577.
PMID: 40009045DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Development
- Organization
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2017
First Posted
January 26, 2017
Study Start
January 26, 2017
Primary Completion
November 12, 2018
Study Completion
November 12, 2018
Last Updated
December 8, 2021
Results First Posted
December 8, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
- Access Criteria
- Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.