Actively Recruiting
Phase 3 Study of TSND-201 Capsules for Treating Post Traumatic Stress Disorder PTSD in Adults
Led by Transcend Therapeutics · Updated on 2026-06-12
300
Participants Needed
32
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of TSND-201 in adults diagnosed with Post Traumatic Stress Disorder PTSD who have had symptoms for at least six months. The study involves participants who have previously tried at least one medication or trauma-focused psychotherapy for PTSD. This phase 3 randomized, double-blind, placebo-controlled trial aims to compare two doses of TSND-201 capsules with a placebo to better understand treatment options for PTSD. Participants will enter a 4-week Treatment Period during which they will be randomly assigned to receive either one of two doses of TSND-201 or a placebo capsule once a week, taken orally. After completing this treatment phase, they will continue into an 8-week Follow-up Period to monitor their progress and any changes in their condition. The study uses a parallel design and masking to keep participants and researchers unaware of group assignments. During the study, participants will undergo assessments including the Clinician-Administered PTSD Scale for DSM-5 CAPS-5 to measure changes in PTSD severity from the start through 12 weeks. Researchers will also monitor safety and efficacy by evaluating participants regularly through interviews and questionnaires. The entire participation duration covers 12 weeks, including treatment and follow-up, with safety and response being closely observed throughout.
CONDITIONS
Brief Title
An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-1)
Research Team
S
Study Director
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