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

Completed · Phase 2

Conditions studied: Post Traumatic Stress Disorder

In brief

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).

Key facts

Study ID

NCT06215261

Run by

Transcend Therapeutics

People needed

62

Starts

2024-04-04

Expected to finish

2025-09-23

Last updated by the study team

2025-11-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 pharmacological treatment).
• Proficient in reading and writing in local language sufficient to complete 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) <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/cerebrovascular conditions.

Where it is running

• Segal Trials — Lauderhill, Florida, United States
• Accel Research — Maitland, Florida, United States
• CNS Healthcare — Orlando, Florida, United States
• Uptown Clinical Research — Chicago, Illinois, United States
• Sunstone Medical — Rockville, Maryland, United States
• Redbird Research LLC — Las Vegas, Nevada, United States
• Numinus — Draper, Utah, United States
• Seattle NTC — Bellevue, Washington, United States
• Swinburne University of Technology — Hawthorn, Victoria, Australia
• Ramsay Clinic Albert Road — Melbourne, Victoria, Australia
• Monarch Mental Health Group — Melbourne, Victoria, Australia
• Clerkenwell Health — London, United Kingdom

Full record on ClinicalTrials.gov

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