Evaluating methylone for treating PTSD

An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD IMPACT-2 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])

This study is testing if methylone can help adults with PTSD feel better by looking at its safety and effectiveness over a few weeks of treatment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Transcend Therapeutics (industry)
• Locations: 12 sites (Lauderhill, Florida and 11 other locations)
• Trial ID: NCT06215261 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of methylone in adults diagnosed with PTSD. It consists of two parts: Part A is an open-label phase enrolling up to 15 participants, while Part B is a randomized, single-blind phase enrolling up to 45 participants. Participants will receive methylone once weekly during the treatment periods, which last three weeks for Part A and four weeks for Part B, followed by a follow-up period. The study aims to gather data on the effects of methylone on PTSD symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults who meet DSM-5 criteria for severe PTSD and have tried at least one prior treatment.

Not a fit: Patients with primary diagnoses of other DSM-5 disorders or significant cardiovascular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from PTSD.

How similar studies have performed: While the use of methylone for PTSD is a novel approach, similar studies evaluating neuroplastogens have shown promise in treating mental health conditions.

Eligibility criteria

Inclusion Criteria:

* Meets DSM-5 criteria for severe PTSD diagnosis, with a symptom duration of at least 6 months.
* Tried 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.

Exclusion Criteria:

* Primary diagnosis of any other DSM-5 disorder.
* Body mass index (BMI) \<18kg/m2 or ≥40 kg/m2.
* Smokes an average of \>10 cigarettes and/or e-cigarettes per day.
* Uncontrolled hypertension at Screening.
* Use of prohibited concomitant medications or therapies.
* Current or previous history of clinically significant cardiovascular/cerebrovascular conditions.

Where this trial is running

Lauderhill, Florida and 11 other locations

• Segal Trials — Lauderhill, Florida, United States (RECRUITING)
• Accel Research — Maitland, Florida, United States (RECRUITING)
• CNS Healthcare — Orlando, Florida, United States (RECRUITING)
• Uptown Clinical Research — Chicago, Illinois, United States (RECRUITING)
• Sunstone Medical — Rockville, Maryland, United States (RECRUITING)
• Redbird Research LLC — Las Vegas, Nevada, United States (RECRUITING)
• Numinus — Draper, Utah, United States (RECRUITING)
• Seattle NTC — Bellevue, Washington, United States (RECRUITING)
• Swinburne University of Technology — Hawthorn, Victoria, Australia (COMPLETED)
• Ramsay Clinic Albert Road — Melbourne, Victoria, Australia (COMPLETED)
• Monarch Mental Health Group — Melbourne, Victoria, Australia (COMPLETED)
• Clerkenwell Health — London, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Study Director

Conditions: Post Traumatic Stress Disorder, Methylone, IMPACT-2, PTSD, Neuroplastogen, TSND-201