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NCT05422612 · ClinicalTrials.gov registry record · Phase 2
Department of Defense PTSD Adaptive Platform Trial - Master Protocol
A Phase 2 study of Post Traumatic Stress Disorder, sponsored by Global Coalition for Adaptive Research.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 800
- Enrollment target
- 10
- Study locations
NCT05422612: Recruiting Phase 2 study of Post Traumatic Stress Disorder, sponsored by Global Coalition for Adaptive Research.
NCT05422612 is a Phase 2 study of Post Traumatic Stress Disorder that is actively recruiting participants, run by Global Coalition for Adaptive Research. The registered enrollment target is 800 participants, above the 661-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (21% higher). The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05422612, a Phase 2 study of Post Traumatic Stress Disorder, is actively recruiting participants, sponsored by Global Coalition for Adaptive Research.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 800 participants
- Enrollment target
- 10
- Study locations
Study Summary
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 Studied
Interventions
- DRUG Intervention A Fluoxetine Hydrochloride (HCl)
- DRUG Intervention A Placebo
- DRUG Intervention B Vilazodone Hydrochloride (HCl)
- DRUG Intervention B Placebo
- DRUG Intervention C Daridorexant
Study Locations (10)
Arizona
- Phoenix VA Healthcare System - Phoenix
Florida
- Homestead Associates in Research, Inc. - Miami
Georgia
- Advanced Discovery Research - Atlanta
Hawaii
- Tripler Army Medical Center (TAMC) - Tripler AMC
Kentucky
- Cincinnati Veteran's Affairs Medical Center - Fort Thomas
Maryland
- Walter Reed National Military Medical Center (WRNMC) - Bethesda
New York
- Upstate Clinical Research Associates, LLC - Williamsville
Texas
- Wilford Hall Ambulatory Surgical Center (WHASC) - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2023-11-02 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
What NCT05422612 shows while recruiting
NCT05422612 is an interventional study that assigns participants to a tested intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap, above the 661-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (21% higher).
The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 5 interventions - of which Intervention A Fluoxetine Hydrochloride (HCl) is the first listed.
NCT05422612 lists 10 locations in 10 states (Arizona, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT05422612 about?
NCT05422612 is a clinical study titled "Department of Defense PTSD Adaptive Platform Trial - Master Protocol". 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 ena...
What is the current status of trial NCT05422612?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 800 participants. The study started on 2023-11-02. Estimated completion is 2026-09.
What conditions does trial NCT05422612 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder.
What interventions are being tested in trial NCT05422612?
The interventions under investigation include: Intervention A Fluoxetine Hydrochloride (HCl) (DRUG), Intervention A Placebo (DRUG), Intervention B Vilazodone Hydrochloride (HCl) (DRUG), Intervention B Placebo (DRUG), Intervention C Daridorexant (DRUG).
Who is sponsoring clinical trial NCT05422612?
This trial is sponsored by Global Coalition for Adaptive Research, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05422612 being conducted?
This trial has 10 study locations across Arizona, Florida, Georgia, Hawaii, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Post Traumatic Stress Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05422612's enrollment target sits among peer trials
800 7th of 262 higher than 256 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Department of Defense PTSD Adaptive Platform Trial - Intervention A - Fluoxetine
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-
Facilitation of Extinction Retention and Reconsolidation Blockade by IV Allopregnanolone in PTSD.
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Facilitation of Extinction Retention and Reconsolidation Blockade in PTSD
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MDMA for AUD/PTSD Comorbidity
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Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol (R33)
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Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant
RECRUITING · Phase 2
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