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NCT Number: NCT07456696

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

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.

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mountain Clinical Trials LLC, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TSND-201

Drug

TSND-201 capsules, given orally, once a week for four consecutive weeks

Other names: methylone

Placebo

Drug

Placebo capsules, given orally, once a week for four consecutive weeks

Primary outcomes

  1. Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score

    Time frame: Up to 12 weeks

    CAPS-5 is a structured interview designed to assess PTSD symptoms severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

650-769-6472

Sponsors and collaborators

Lead sponsor

Transcend Therapeutics

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD

Acronym: EMPOWER-1

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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