NCT06215261

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

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])

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Transcend Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Methylone	Methylone capsules, given orally, once a week for 3 weeks (Part A) or 4 weeks (Part B)

Timeline

• Start date: 2024-04-04
• Primary completion: 2025-09-23
• Completion: 2025-09-23
• First posted: 2024-01-22
• Last updated: 2025-11-25

Locations

12 sites across 3 countries: United States, Australia, United Kingdom

Regulatory

• FDA-regulated drug study