An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD
- Registration Number
- NCT06215261
- Lead Sponsor
- Transcend Therapeutics
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TSND-201 Low Dose Methylone Part B only TSND-201 Mid Dose Methylone Part B only TSND-201 High Dose Methylone Part B only
- Primary Outcome Measures
Name Time Method Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score 9 weeks (Part A) / 12 weeks (Part B) The CAPS-5 is a structured interview designed to assess PTSD symptom severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score 9 weeks (Part A) / 12 weeks (Part B) The MADRS is a 10-item, clinician-rated scale designed to assess severity of depression. The total score ranges from 0 to 60, with a higher score indicating more severe depression.
Change from Baseline in Sheehan Disability Scale (SDS) 9 weeks (Part A) / 12 weeks (Part B) The SDS is a 3-item, patient-rated scale designed to measure disability and impairment across three domains: work/school, social life, and family life/home responsibilities. Each domain is scored from 0 to 10, with higher scores representing greater disability. Total scores range from 0 to 30.
Change from Baseline in PTSD Checklist for DSM-5 (PCL-5) 9 weeks (Part A) / 12 weeks (Part B) The PCL-5 is a 20-item, patient-rated scale designed to measure severity of PTSD symptoms. The total score ranges from 0 to 80, with a higher score indicating more severe PTSD symptoms.
Incidence of treatment-emergent adverse events (TEAEs) 9 weeks (Part A) / 12 weeks (Part B) Types and rates of adverse events
Trial Locations
- Locations (12)
Accel Research
🇺🇸Maitland, Florida, United States
Sunstone Medical
🇺🇸Rockville, Maryland, United States
Redbird Research LLC
🇺🇸Las Vegas, Nevada, United States
Numinus
🇺🇸Draper, Utah, United States
Seattle NTC
🇺🇸Bellevue, Washington, United States
Segal Trials
🇺🇸Lauderhill, Florida, United States
CNS Healthcare
🇺🇸Orlando, Florida, United States
Uptown Clinical Research
🇺🇸Chicago, Illinois, United States
Swinburne University of Technology
🇦🇺Hawthorn, Victoria, Australia
Ramsay Clinic Albert Road
🇦🇺Melbourne, Victoria, Australia
Monarch Mental Health Group
🇦🇺Melbourne, Victoria, Australia
Clerkenwell Health
🇬🇧London, United Kingdom