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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Post Traumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT07456696

Run by

Transcend Therapeutics

People needed

300

Starts

2026-04-02

Expected to finish

2027-12-01

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Del Sol Research — Tucson, Arizona, United States (enrolling)
• Preferred Research Partners — Little Rock, Arkansas, United States (enrolling)
• Kadima Neuropsychiatry — La Jolla, California, United States (enrolling)
• CalNeuro Research Group — Los Angeles, California, United States (enrolling)
• Catalina Research Institute — Montclair, California, United States (enrolling)
• Excell Research — Oceanside, California, United States (enrolling)
• ATP Clinical Research — Orange, California, United States (enrolling)
• Inland Psychiatric Medical Group — San Juan Capistrano, California, United States (enrolling)
• Starlight Clinical Research — Evergreen, Colorado, United States (enrolling)
• CNS Healthcare — Jacksonville, Florida, United States (enrolling)
• Segal Trials — Lauderhill, Florida, United States (enrolling)
• Accel Clinical Research — Maitland, Florida, United States (enrolling)
• CNS Healthcare — Orlando, Florida, United States (enrolling)
• Uptown Research Institute — Chicago, Illinois, United States (enrolling)
• DelRicht - New Orleans — New Orleans, Louisiana, United States (enrolling)
• Headlands Research - Pharmasite — Pikesville, Maryland, United States (enrolling)
• Vitalix Clinical — Worcester, Massachusetts, United States (enrolling)
• Arch Clinical Trials — Creve Coeur, Missouri, United States (enrolling)
• Midwest Research Group — Saint Charles, Missouri, United States (enrolling)
• Center for Emotional Fitness/ Lumina Clinical Research Center — Cherry Hill, New Jersey, United States (enrolling)
• Global Medical Institutes — Princeton, New Jersey, United States (enrolling)
• Bio Behavioral Health — Toms River, New Jersey, United States (enrolling)
• Medical Research Network — New York, New York, United States (enrolling)
• Insight Clinical Trials — Independence, Ohio, United States (enrolling)
• Flourish Research — Plymouth Meeting, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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