An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD - Trial NCT06215261
Access comprehensive clinical trial information for NCT06215261 through Pure Global AI's free database. This Phase 2 trial is sponsored by Transcend Therapeutics and is currently Not yet recruiting. The study focuses on Post Traumatic Stress Disorder. Target enrollment is 79 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
Transcend Therapeutics
Timeline & Enrollment
Phase 2
Mar 01, 2024
Dec 01, 2025
Primary Outcome
Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score
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), double-blind, placebo-controlled and will enroll up to 64
 participants with PTSD
 
 Eligible participants will enter a 3-week Treatment Period where they will receive methylone
 (or placebo in Part B) once weekly for 3 weeks (3 treatment sessions). Following the
 Treatment Period, participants will enter a 6-week Follow-up Period.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06215261
Non-Device Trial