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

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.

Timeline

Start

2023-03-01

Primary completion

2025-02-19

Completion

2025-02-19

Publications

• Results Jones A, Warner-Schmidt J, Kwak H, Stogniew M, Mandell B, Ching THW, Stein MB, Kelmendi B. Efficacy and Safety of the Neuroplastogen TSND-201 for the Treatment of PTSD: A Randomized Clinical Trial. JAMA Psychiatry. 2026 May 1;83(5):469-477. doi: 10.1001/jamapsychiatry.2025.4625.

Drugs

Indications