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RECRUITING Phase 3 ClinicalTrials.gov

An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-1)

Sponsor: Transcend Therapeutics • ClinicalTrials.gov ID: NCT07456696

Registry updated: 2026-09-17
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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 the 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) \<18 kg/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 Clinical Trials LLC — Phoenix, Arizona, United States
  • Del Sol Research — Tucson, Arizona, United States
  • Preferred Research Partners — Little Rock, Arkansas, United States
  • Sun Valley Research — Imperial, California, United States
  • Kadima Neuropsychiatry — La Jolla, California, United States
  • CalNeuro Research Group — Los Angeles, California, United States
  • Catalina Research Institute — Montclair, California, United States
  • Excell Research — Oceanside, California, United States
  • ATP Clinical Research — Orange, California, United States
  • Inland Psychiatric Medical Group — San Juan Capistrano, California, United States
  • Starlight Clinical Research — Evergreen, Colorado, United States
  • CNS Healthcare — Jacksonville, Florida, United States
  • Segal Trials — Lauderhill, Florida, United States
  • Accel Clinical Research — Maitland, Florida, United States
  • CNS Healthcare — Orlando, Florida, United States
  • TrialMed — Atlanta, Georgia, United States
  • Uptown Research Institute — Chicago, Illinois, United States
  • DelRicht - New Orleans — New Orleans, Louisiana, United States
  • Headlands Research - Pharmasite — Pikesville, Maryland, United States
  • Vitalix Clinical — Worcester, Massachusetts, United States
  • Arch Clinical Trials — Creve Coeur, Missouri, United States
  • Midwest Research Group — Saint Charles, Missouri, United States
  • Center for Emotional Fitness/ Lumina Clinical Research Center — Cherry Hill, New Jersey, United States
  • Global Medical Institutes — Princeton, New Jersey, United States
  • Bio Behavioral Health — Toms River, New Jersey, United States
  • Medical Research Network — New York, New York, United States
  • Insight Clinical Trials — Independence, Ohio, United States
  • Flourish Research — Plymouth Meeting, Pennsylvania, United States
  • Suburban Research Associates — West Chester, Pennsylvania, United States
  • CNS Memphis — Memphis, Tennessee, United States
  • Austin Clinical Trial Partners — Austin, Texas, United States
  • Haracec Clinical Research — El Paso, Texas, United States
  • Elevate Clinical Research — Houston, Texas, United States
  • Cedar Clinical Research — Draper, Utah, United States
  • Inner Space Research — Orem, Utah, United States
  • Seattle Neuropsychiatric Treatment Center (NTC) — Seattle, Washington, United States
  • Wisconsin-Madison — Madison, Wisconsin, 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