Department of Defense PTSD Adaptive Platform Trial – Intervention D – SLS-002

This Phase II randomised, quadruple-blind, placebo-controlled trial (n=200) will assess the safety and efficacy of intranasal SLS-002 (ketamine, 78mg) for post-traumatic stress disorder (PTSD) in active-duty service members and veterans.

The study, part of the Department of Defense PTSD Adaptive Platform Trial, is sponsored by the Global Coalition for Adaptive Research. It employs an adaptive platform trial (APT) design, meaning multiple potential PTSD treatments are tested simultaneously with shared control groups.

Participants are randomly assigned to either the SLS-002 group or a placebo group (5:3 ratio). Treatment involves intranasal administration of SLS-002 twice weekly for eight weeks, then once weekly for four weeks. The primary outcome measure is the change in PTSD symptom severity over 12 weeks using the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R). Safety outcomes include monitoring suicidal thoughts, adverse events, and cardiovascular effects. The trial is expected to begin in June 2025 and conclude in September 2026, with study sites across the United States.

Topic PTSD
Compound Ketamine Placebo
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 June 2025
End date 01 September 2026
Phase Phase II
Design Blinded
Type Interventional
Generation Second
Participants 200
Sex All
Age 18- 65
Therapy No

Trial Details

This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for Post Traumatic Stress Disorder (PTSD) utilizing an adaptive platform trial (APT) design. Intervention D - SLS-002 will assess the safety and efficacy of SLS-002 in participants with PTSD. Please see NCT05422612 for information on the S-21-02 Master Protocol.

Trial Number NCT06816433

Data attribution

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