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

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Transcend Therapeutics

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.