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An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD
Sponsor: Transcend Therapeutics
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).
Official title: An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD IMPACT-2 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
62
Start Date
2024-04-04
Completion Date
2025-09-23
Last Updated
2026-10-30
Healthy Volunteers
No
Conditions
Interventions
Methylone
Methylone capsules, given orally, once a week for 3 weeks (Part A) or 4 weeks (Part B)
Locations (12)
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