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

NCT06215261 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-11-25

No results posted yet for this study

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

DRUG

Methylone

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

Sponsors & Collaborators

  • Transcend Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-04
Primary Completion
2025-09-23
Completion
2025-09-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06215261 on ClinicalTrials.gov