An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD

Last updated: April 14, 2025
Sponsor: Transcend Therapeutics
Overall Status: Active - Recruiting

Phase

2

Condition

Post-traumatic Stress Disorders

Treatment

Methylone

Placebo

Clinical Study ID

NCT06215261
TSND201-PTSD-202
  • Ages 18-70
  • All Genders

Study Summary

This study is evaluating the safety and efficacy of methylone in adults with PTSD. The study is conducted in two parts.

  • Part A is open-label and will enroll up to 15 participants with PTSD

  • Part B is randomized (1:1:1), single-blind and will enroll up to 45 participants with PTSD

Eligible participants will enter a 3-week Treatment Period (Part A) or 4-week Treatment Period (Part B) where they will receive methylone once weekly. Following the Treatment Period, participants will enter a 6-week Follow-up Period (Part A) or 8-week Follow-up Period (Part B).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meets DSM-5 criteria for severe PTSD diagnosis, with a symptom duration of at least 6 months.

  • Tried at least one treatment for PTSD (either psychotherapy or pharmacologicaltreatment).

  • Proficient in reading and writing in local language sufficient to completequestionnaires.

  • Free from any other clinically significant illness or disease.

Exclusion

Exclusion Criteria:

  • Primary diagnosis of any other DSM-5 disorder.

  • Body mass index (BMI) <18kg/m2 or ≥40 kg/m2.

  • Smokes an average of >10 cigarettes and/or e-cigarettes per day.

  • Uncontrolled hypertension at Screening.

  • Use of prohibited concomitant medications or therapies.

  • Current or previous history of clinically significant cardiovascular/cerebrovascularconditions.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Methylone
Phase: 2
Study Start date:
April 04, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Swinburne University of Technology

    Hawthorn, Victoria 3122
    Australia

    Completed

  • Monarch Mental Health Group

    Melbourne, Victoria
    Australia

    Completed

  • Ramsay Clinic Albert Road

    Melbourne, Victoria 3004
    Australia

    Completed

  • Clerkenwell Health

    London,
    United Kingdom

    Active - Recruiting

  • Segal Trials

    Lauderhill, Florida 33319
    United States

    Active - Recruiting

  • Accel Research

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • CNS Healthcare

    Orlando, Florida 32801
    United States

    Active - Recruiting

  • Uptown Clinical Research

    Chicago, Illinois 60640
    United States

    Active - Recruiting

  • Sunstone Medical

    Rockville, Maryland 20850
    United States

    Active - Recruiting

  • Redbird Research LLC

    Las Vegas, Nevada 89119
    United States

    Active - Recruiting

  • Numinus

    Draper, Utah 84020
    United States

    Active - Recruiting

  • Seattle NTC

    Bellevue, Washington 98004
    United States

    Active - Recruiting

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