RecruitingPhase 2NCT05422612

Department of Defense PTSD Adaptive Platform Trial - Master Protocol

A Phase 2, Multi-center, Multi-arm, Randomized, Placebo-controlled, Double-blind, Adaptive Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Potential Pharmacotherapeutic Interventions in Active-Duty Service Members and Veterans With PTSD

Sponsor

Global Coalition for Adaptive Research

Enrollment

800 participants

Start Date

Nov 2, 2023

Study Type

INTERVENTIONAL

Conditions

Post Traumatic Stress Disorder

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This is a large, flexible clinical trial (called an adaptive platform trial) testing multiple treatments for post-traumatic stress disorder (PTSD) specifically in U.S. military veterans and active-duty service members. **You may be eligible if:** - You are between 18 and 64 years old - You are a current or former U.S. military member (including Reserves and National Guard) - You have been diagnosed with PTSD based on a structured clinical interview - Your PTSD symptoms are moderately severe or higher (score of 26 or above on the CAPS-5 scale) - The traumatic event happened more than 3 months ago - You are willing to use reliable birth control if applicable **You may NOT be eligible if:** - You do not have a PTSD diagnosis - You are not affiliated with any branch of the U.S. military - Your trauma occurred within the past 3 months - You are pregnant or breastfeeding (specific requirements vary by treatment arm) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntervention 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.

DRUGIntervention A Placebo

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

DRUGIntervention 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.

DRUGIntervention B Placebo

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

DRUGIntervention C Daridorexant

Daridorexant will be administered 50 mg once daily.

DRUGIntervention C Placebo

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

DRUGIntervention 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.

DRUGIntervention 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.