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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 22 May 2025

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At a glance

  • Drugs Daridorexant (Primary) ; Fluoxetine (Primary) ; Ketamine (Primary) ; Vilazodone (Primary)
  • Indications Post-traumatic stress disorders
  • Focus Therapeutic Use

Most Recent Events

  • 07 Feb 2025 Planned number of patients changed from 600 to 800.
  • 24 Sep 2024 According to a Seelos Therapeutics media release, the company has announced the signing of a Material Transfer Agreement (MTA) with the U.S. Army Medical Materiel Development Activity (USAMMDA) to supply SLS-002 for the U.S. Department of Defense's (DOD) Military and Veterans Adaptive Platform Clinical Trial ("M-PACT") to evaluate its potential for treatment of post-traumatic stress disorder (PTSD). Dosing of the SLS-002 cohort is expected to commence in 4Q2024.
  • 27 Nov 2023 According to a Seelos Therapeutics media release, SLS-002 (intranasal racemic ketamine) has been selected for inclusion in this study.

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