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RECRUITING Phase 3 ClinicalTrials.gov

An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD

Sponsor: Transcend Therapeutics • ClinicalTrials.gov ID: NCT07836647

Registry updated: 2026-09-23
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Description

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.

Interventions

  • TSND-201 (Drug)
    TSND-201 capsules, given orally, once a week for four consecutive weeks
  • Placebo (Drug)
    Placebo capsules, given orally, once a week for four consecutive weeks

Eligibility criteria

Inclusion Criteria: * Meets DSM-5 criteria for current PTSD diagnosis, with a symptom duration of at least 6 months. * Tried at least one pharmacological treatment for PTSD or trauma-focused psychotherapy. * Proficient in communication (verbal and reading) to complete interviews and written questionnaires. * Free from any other clinically significant illness or disease. Exclusion Criteria: * Primary diagnosis of any other DSM-5 disorder. * Body mass index (BMI) \<18kg/m2 or ≥40 kg/m2. * Unable to refrain from nicotine use for at least 8 hours. * Use of prohibited concomitant medications or therapies. * Current or previous history of clinically significant cardiovascular (including current uncontrolled hypertension) / cerebrovascular conditions.

Conditions

Post Traumatic Stress Disorder

Locations

  • Mountain View Clinical Research — Denver, Colorado, United States
  • Bradenton Research Center — Bradenton, Florida, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record