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

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.

Description

Eligibility

Age range

18–65 years

Sex

All

Healthy volunteers

Yes

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.

Locations (10)