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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 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, below the 1,111-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (28% lower). The trial reports 10 study locations across 10 states.

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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

Post Traumatic Stress Disorder

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

FieldValue
Enrollment Target 800 participants
Start Date 2023-11-02
Est. Completion 2026-09
Phase Phase 2

Sponsor

Global Coalition for Adaptive Research

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05422612

The ClinicalTrials.gov registry entry for NCT05422612 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,111-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (28% lower). The listed sponsor is Global Coalition for Adaptive Research, which has 4 total studies on file at ClinicalTrials.gov.

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 reports 10 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.