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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Post Traumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT05741710

Run by

Transcend Therapeutics

People needed

79

Starts

2023-03-01

Expected to finish

2025-02-19

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets the DSM-5 criteria for current moderate to severe PTSD diagnosis, with a symptom duration of at least 6 months
• CAPS-5 score of ≥35 at Screening.
• Failed at least one treatment for PTSD (either psychotherapy or pharmacological treatment).
• Proficient in reading and writing in local language sufficient to complete questionnaires.
• Free from any other clinically significant illness or disease

You may not qualify if…

• Primary diagnosis of any other DSM-5 disorder
• Body mass index (BMI) <18 kg/m2 or ≥40 kg/m2.
• Smokes an average of >10 cigarettes and/or e-cigarettes per day
• Uncontrolled hypertension at Screening
• Use of a psychedelic (e.g., LSD, psilocybin, DMT, mescaline), or entactogens such as MDMA, within 12 months of Screening.
• Use of an SSRI or other antidepressant within 8 weeks of screening.
• Current or previous history of clinically significant cardiovascular/cerebrovascular conditions.

Where it is running

• Mountain View Clinical Research — Denver, Colorado, United States
• Clinical Neuroscience Solutions - Jacksonville — Jacksonville, Florida, United States
• Accel Research Sites — Maitland, Florida, United States
• Sunstone Therapies — Rockville, Maryland, United States
• Boston Clinical Trials — Boston, Massachusetts, United States
• Cenexel HRI — Berlin, New Jersey, United States
• The Rivus Wellness & Research Institute — Oklahoma City, Oklahoma, United States
• Cedar Clinical Research — Murray, Utah, United States
• Tallaght Adult Mental Health Services — Dublin, Ireland
• La Nua Day Hospital Mental Health Centre — Galway, Ireland
• Mirabilis Health — Belfast, Northern Ireland, United Kingdom
• Cambridge University Hospitals NHS Foundation Trust — Cambridge, United Kingdom
• Glasgow Clinical Research Facility, QEUH — Glasgow, United Kingdom
• Clerkenwell Health — London, United Kingdom
• King's College — London, United Kingdom
• Oxford Health NHS Foundation Trust — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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