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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTranscend Therapeutics

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • TSND-201
  • Placebo

Treatment groups

300 Participants
are divided into 3 treatment groups

Sponsors and collaborators