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An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-1)
Sponsor: Transcend Therapeutics
Summary
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.
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-04-02
Completion Date
2027-12
Last Updated
2026-05-20
Healthy Volunteers
No
Conditions
Interventions
TSND-201
TSND-201 capsules, given orally, once a week for four consecutive weeks
Placebo
Placebo capsules, given orally, once a week for four consecutive weeks
Locations (26)
Preferred Research Partners
Little Rock, Arkansas, 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
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
Uptown Research Institute
Chicago, Illinois, United States
Headlands Research - Pharmasite
Pikesville, Maryland, United States
Vitalix Clinical
Worcester, Massachusetts, 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
Austin Clinical Trial Partners
Austin, Texas, United States
Haracec Clinical Research
El Paso, Texas, United States
Inner Space Research
Orem, Utah, United States
Seattle Neuropsychiatric Treatment Center (NTC)
Seattle, Washington, United States