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An Evaluation of the Long-term Efficacy and Safety of Methylone for the Treatment of PTSD — IMPACT-EXT  

Post Traumatic Stress Disorder Clinical Trial

Official title:
A 52-Week, Open-Label Evaluation of the Long-term Efficacy and Safety of Single and Repeated Treatments With Methylone for the Treatment of PTSD IMPACT-EXT (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])

Clinical Trial Summary

This is an extension study of participants who previously completed a Transcend-sponsored clinical trial with methylone as a treatment for PTSD (IMPACT-1 or IMPACT-2). Participants will be followed for up to 52 weeks. During the 52 week period, PTSD symptoms and safety will be assessed monthly. Participants' PTSD symptoms will be assessed at each observational visit and if criteria for Relapse has been met, participants may be eligible to receive a course of methylone treatment. After a course of methylone treatment, participants resume observational study visits until Week 52.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06237426
Study type Interventional
Source Transcend Therapeutics
Contact
Status Enrolling by invitation
Phase Phase 2
Start date March 6, 2024
Completion date May 2027
View Details
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