Department of Defense PTSD Adaptive Platform Trial - Master Protocol

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

• Post Traumatic Stress Disorder

Interventions

DRUG

Intervention A Fluoxetine Hydrochloride (HCl)

Fluoxetine will be administered at 10 to 60 mg daily. The initial dose for all participants will be 10 mg daily for 1 week, then increased to 20 mg daily for 2 weeks, then increased to 40 mg daily for 2 weeks, then increased to 60 mg daily for the remainder of the trial. One reduction in dose due to tolerability will be allowed. When a participant's dose is decreased due to tolerability, the dose will not be increased.

DRUG

Intervention A Placebo

A matching placebo will be administered at 10 to 60 mg daily in the same regimen as the intervention.

DRUG

Intervention B Vilazodone Hydrochloride (HCl)

Vilazodone HCl will be administered at 10 mg once daily for 7 days, followed by 20 mg for 7 days, followed by 40 mg for the remainder of the trial. There must be a minimum of 7 days between dosage increases. One reduction in dose due to tolerability will be allowed. After Week 8, dose reduction for tolerability is allowed, but dose increase is not allowed.

DRUG

Intervention B Placebo

A matching placebo will be administered at 10 to 40 mg daily in the same regimen as the intervention.

DRUG

Intervention C Daridorexant

Daridorexant will be administered 50 mg once daily.

DRUG

Intervention C Placebo

A matching placebo will be administered at 50 mg daily in the same regimen as the intervention.

DRUG

Intervention D SLS-002

• SLS-002 will be administered via intranasal administration (one spray per nostril, per device) at 78 mg two times per week for the first eight weeks and then once a week for the last four weeks.

DRUG

Intervention D Placebo

A matching placebo will be administered via intranasal administration (one spray per nostril, per device) two times per week for the first eight weeks and then once a week for the last four weeks.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command

  collaborator FED

• PPD Development, LP

  collaborator INDUSTRY

• Berry Consultants

  collaborator OTHER

• Idorsia Pharmaceuticals Ltd.

  collaborator INDUSTRY

• Cambridge Cognition Ltd

  collaborator INDUSTRY

• Citeline

  collaborator INDUSTRY

• Global Coalition for Adaptive Research

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-11-02

Primary Completion

2026-03-31

Completion

2026-09-30

FDA Drug

Yes

Countries

• United States

Study Locations