A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
Status: Recruiting
Location: See all (32) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arkansas
Preferred Research Partners
RECRUITING
Little Rock
Arizona
Del Sol Research
RECRUITING
Tucson
California
Kadima Neuropsychiatry
RECRUITING
La Jolla
CalNeuro Research Group
RECRUITING
Los Angeles
Catalina Research Institute
RECRUITING
Montclair
Excell Research
RECRUITING
Oceanside
ATP Clinical Research
RECRUITING
Orange
Inland Psychiatric Medical Group
RECRUITING
San Juan Capistrano
Colorado
Starlight Clinical Research
RECRUITING
Evergreen
Florida
CNS Healthcare
RECRUITING
Jacksonville
Segal Trials
RECRUITING
Lauderhill
Accel Clinical Research
RECRUITING
Maitland
CNS Healthcare
RECRUITING
Orlando
Illinois
Uptown Research Institute
RECRUITING
Chicago
Louisiana
DelRicht - New Orleans
RECRUITING
New Orleans
Massachusetts
Vitalix Clinical
RECRUITING
Worcester
Maryland
Headlands Research - Pharmasite
RECRUITING
Pikesville
Missouri
Arch Clinical Trials
RECRUITING
Creve Coeur
Midwest Research Group
RECRUITING
Saint Charles
New Jersey
Center for Emotional Fitness/ Lumina Clinical Research Center
RECRUITING
Cherry Hill
Global Medical Institutes
RECRUITING
Princeton
Bio Behavioral Health
RECRUITING
Toms River
New York
Medical Research Network
RECRUITING
New York
Ohio
Insight Clinical Trials
RECRUITING
Independence
Pennsylvania
Flourish Research
RECRUITING
Plymouth Meeting
Suburban Research Associates
RECRUITING
West Chester
Texas
Austin Clinical Trial Partners
RECRUITING
Austin
Haracec Clinical Research
RECRUITING
El Paso
Elevate Clinical Research
RECRUITING
Houston
Utah
Cedar Clinical Research
RECRUITING
Draper
Inner Space Research
RECRUITING
Orem
Washington
Seattle Neuropsychiatric Treatment Center (NTC)
RECRUITING
Seattle
Contact Information
Primary
Study Director
amanda@transcendtherapeutics.com
650-769-6472
Time Frame
Start Date: 2026-04-02
Estimated Completion Date: 2027-12
Participants
Target number of participants: 300
Treatments
Experimental: TSND-201, Dose Level 1
Experimental: TSND-201, Dose Level 2
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Transcend Therapeutics