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A Study to Assess the Use of Methylone in the Treatment of PTSD

NCT05741710 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2026-04-15

Study results available
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Summary

This study is evaluating the safety, tolerability, and efficacy of methylone in adults with PTSD. The study will be 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 4-week Treatment Period where they will receive methylone once weekly for 4 weeks (4 treatment sessions). Following the Treatment Period, participants will enter a 6-week Follow-up Period which includes 3 reflection visits (Week 4, 5, and 6) and a final study visit at Week 10.

Conditions

  • Post Traumatic Stress Disorder

Interventions

DRUG

Methylone

Methylone capsules, given orally, once a week for 4 weeks

DRUG

Placebo

Placebo capsules to match methylone, given orally, once a week for 4 weeks. NOTE: Placebo is only in 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
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-02-19
Completion
2025-02-19
FDA Drug
Yes

Countries

  • United States
  • Ireland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT05741710 on ClinicalTrials.gov