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

NCT06816433 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-05-20

No results posted yet for this study

Summary

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.

Conditions

  • Post Traumatic Stress Disorder

Interventions

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
2028-05-31
Primary Completion
2029-05-31
Completion
2029-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06816433 on ClinicalTrials.gov