Department of Defense PTSD Adaptive Platform Trial - Master Protocol

Conditions

• Post Traumatic Stress Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• Intervention A Fluoxetine Hydrochloride (HCl) — DRUG
  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.
• Intervention A Placebo — DRUG
  A matching placebo will be administered at 10 to 60 mg daily in the same regimen as the intervention.
• Intervention B Vilazodone Hydrochloride (HCl) — DRUG
  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.
• Intervention B Placebo — DRUG
  A matching placebo will be administered at 10 to 40 mg daily in the same regimen as the intervention.
• Intervention C Daridorexant — DRUG
  Daridorexant will be administered 50 mg once daily.
• Intervention C Placebo — DRUG
  A matching placebo will be administered at 50 mg daily in the same regimen as the intervention.
• Intervention D SLS-002 — DRUG
  • 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.
• Intervention D Placebo — DRUG
  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.

Study Details

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 available 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). The master protocol describes the default procedures and analyses for all cohorts; treatment-specific eligibility requirements, safety and efficacy procedures, or endpoints are described in the cohort-specific appendices and reflected in the intervention-specific clinicaltrials.gov records.

Key Dates

First listed

Jun 16, 2022

Start date

Nov 2, 2023

Status verified

Jun 2026

Primary completion

Jul 31, 2028

Completion

Jul 31, 2029

Study Design

Enrollment

800 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Intervention A: Fluoxetine HCl
• Placebo Comparator: Intervention A Placebo
• Experimental: Intervention B Vilazodone HCl
• Placebo Comparator: Intervention B Placebo
• Experimental: Intervention C Daridorexant
• Placebo Comparator: Intervention C Placebo
• Experimental: Intervention D SLS-002
• Placebo Comparator: Intervention D Placebo

Primary Outcome Measure

Absolute change in the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) Past Month total score at Week 12 (Final/Early termination Visit). [ Time Frame: 12 Weeks ]

Locations (9)

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