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COMPLETED
NCT06215261
PHASE2

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

Sponsor: Transcend Therapeutics

View on ClinicalTrials.gov

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

Interventions

DRUG

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