Overview
This study is evaluating the safety and efficacy of methylone in adults with PTSD. The study is conducted in two parts.
- Part A is open-label and will enroll up to 15 participants with PTSD
- Part B is randomized (1:1:1), single-blind and will enroll up to 45 participants with PTSD
Eligible participants will enter a 3-week Treatment Period (Part A) or 4-week Treatment Period (Part B) where they will receive methylone once weekly. Following the Treatment Period, participants will enter a 6-week Follow-up Period (Part A) or 8-week Follow-up Period (Part B).
Eligibility
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.