Actively Recruiting
Department of Defense PTSD Adaptive Platform Trial - Master Protocol
Led by Global Coalition for Adaptive Research · Updated on 2025-09-08
800
Participants Needed
10
Research Sites
147 weeks
Total Duration
On this page
Sponsors
G
Global Coalition for Adaptive Research
Lead Sponsor
U
U.S. Army Medical Research and Development Command
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for PTSD utilizing an adaptive platform trial design. Participants are randomized among the multiple cohorts in the study and the resulting randomization enables sharing/pooling of control participants, where all interventions may be compared to a common control (placebo). This master protocol describes the default procedures and analyses for all cohorts; treatment-specific procedures will be described in the Master Protocol cohort-specific appendices. Individual cohorts may have additional eligibility requirements, safety and efficacy procedures, or endpoints, which will be described in corresponding intervention-specific clinicaltrials.gov records.
CONDITIONS
Official Title
Department of Defense PTSD Adaptive Platform Trial - Master Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent.
- Aged 18 to less than 65 years at screening.
- Meets DSM-5 criteria for PTSD based on CAPS-5-R assessment at screening and baseline.
- Experienced the index trauma more than 3 months before screening.
- Has a CAPS-5-R total score of 26 or higher at screening and baseline.
- Currently serving or previously served in a branch of the US military including Reserves and National Guard.
- Agrees to consistently use acceptable birth control methods if of reproductive potential and sexually active, as defined for males and females.
- Able and willing to participate in study assessments and blood draws.
- Willing to undergo MRI and has no contraindications to MRI.
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study.
- At risk for suicide including recent suicidal ideation or behavior requiring hospitalization, multiple suicide attempts in last 3 years, or history of suicide-related hospitalization or ideation following psychiatric medications.
- Taking prohibited medications or unable/unwilling to discontinue medications requiring washout prior to study.
- Started or stopped PTSD-specific psychotherapy in last 3 months or plans to end therapy during study, except stable ongoing therapy.
- Underwent or planning gender reassignment surgery; stable hormone therapy allowed.
- Moderate or severe alcohol use disorder or other substance use disorders within 3 months; nicotine use disorder allowed.
- Positive screen for illicit drugs (excluding cannabis) or recent heavy alcohol use at baseline.
- History or current symptoms of psychotic features.
- Unmanaged obstructive sleep apnea with AHI 5 or higher.
- History of cancer or treatment within last 5 years except certain skin cancers.
- Clinically significant abnormal ECG findings.
- Abnormal kidney or liver function lab results exceeding specified thresholds.
- Prior drug-induced liver injury with specified lab criteria.
- Any other clinically significant lab abnormalities or medical/psychiatric conditions impacting safety or participation.
- No stable contact method during study.
- Involved in litigation or disability evaluation related to PTSD.
- Participation in other interventional trials within 3 months or 5 half-lives.
- Unavailable for trial duration or unlikely to comply.
- Blood pressure outside specified ranges (systolic >140 or <90 mm Hg, diastolic >90 or <50 mm Hg).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Phoenix VA Healthcare System
Phoenix, Arizona, United States, 85012-1839
Actively Recruiting
2
Homestead Associates in Research, Inc.
Miami, Florida, United States, 33032
Actively Recruiting
3
Advanced Discovery Research
Atlanta, Georgia, United States, 30318
Actively Recruiting
4
Tripler Army Medical Center (TAMC)
Tripler AMC, Hawaii, United States, 96859
Actively Recruiting
5
Cincinnati Veteran's Affairs Medical Center
Fort Thomas, Kentucky, United States, 41075
Actively Recruiting
6
Walter Reed National Military Medical Center (WRNMC)
Bethesda, Maryland, United States, 20889-5632
Actively Recruiting
7
Upstate Clinical Research Associates, LLC
Williamsville, New York, United States, 14221
Actively Recruiting
8
Wilford Hall Ambulatory Surgical Center (WHASC)
San Antonio, Texas, United States, 78236
Actively Recruiting
9
Alexander T. Augusta Military Medical Center (ATAMMC):
Fort Belvoir, Virginia, United States, 22060-5285
Actively Recruiting
10
Madigan Army Medical Center
Joint Base Lewis McChord, Washington, United States, 98433
Actively Recruiting
Research Team
P
Please visit the website:
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here