TSND-201 treatment for adults with PTSD (EMPOWER-1)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

EMPOWER-1 is a Phase 3, randomized, double-blind trial that assigns eligible adults with DSM-5 PTSD 1:1:1 to one of two doses of TSND-201 or placebo given once weekly during a 4-week treatment period, followed by an 8-week follow-up. Participants must have had PTSD symptoms for at least six months and previously tried at least one pharmacologic treatment or trauma-focused psychotherapy. Key exclusions include a primary diagnosis other than PTSD, significant cardiovascular or cerebrovascular disease (including uncontrolled hypertension), extreme BMI (<18 or ≥40 kg/m2), use of prohibited concomitant therapies, or inability to refrain from nicotine as required. Safety and symptom change over the treatment and follow-up periods are the main outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mountain Clinical Trials LLC
  Phoenix, Arizona, United States Recruiting
• Del Sol Research
  Tucson, Arizona, United States Recruiting
• Preferred Research Partners
  Little Rock, Arkansas, United States Recruiting
• Sun Valley Research
  Imperial, California, United States Recruiting
• Kadima Neuropsychiatry
  La Jolla, California, United States Recruiting
• CalNeuro Research Group
  Los Angeles, California, United States Recruiting

Study contacts

• Study coordinator: Study Director
• Email: amanda@transcendtherapeutics.com
• Phone: 650-769-6472

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.