A Phase 3 interventional study of TSND-201 and Placebo in Post Traumatic Stress Disorder, sponsored by Transcend Therapeutics. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Transcend Therapeutics · Phase 3, Interventional, and Treatment
This study is evaluating the safety and efficacy of TSND-201 in adults with PTSD. Eligible participants will enter a 4-week Treatment Period where they will be randomized 1:1:1 to receive one of two doses of TSND-201 or placebo, once per week. Following the Treatment Period, participants will enter an 8-week Follow-up Period.
Exclusion Criteria:
Drug: TSND-201
Drug: TSND-201
Drug: Placebo
TSND-201 capsules, given orally, once a week for four consecutive weeks
Also known as: methylone
Placebo capsules, given orally, once a week for four consecutive weeks
Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
CAPS-5 is a structured interview designed to assess PTSD symptoms severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.
Time frame: Up to 12 Weeks
Plan to share: No
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Stress Disorders, Post-Traumatic→
Transcend Therapeutics