A Study to Assess the Use of Methylone in the Treatment of PTSD
- Registration Number
- NCT05741710
- Lead Sponsor
- Transcend Therapeutics
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Methylone Methylone - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score up to 10 weeks CAPS-5 is a structured interview designed to assess PTSD symptoms 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 PTSD Checklist for DSM-5 (PCL-5) up to 10 weeks 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) up to 10 weeks Type and rates of adverse events
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score up to 10 weeks 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) up to 10 weeks 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 represented more disability. Total sores range from 0 to 30.
Trial Locations
- Locations (16)
Mountain View Clinical Research
🇺🇸Denver, Colorado, United States
Sunstone Therapies
🇺🇸Rockville, Maryland, United States
Clinical Neuroscience Solutions - Jacksonville
🇺🇸Jacksonville, Florida, United States
Accel Research Sites
🇺🇸Maitland, Florida, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Cenexel HRI
🇺🇸Berlin, New Jersey, United States
Mirabilis Health
🇬🇧Belfast, Northern Ireland, United Kingdom
The Rivus Wellness & Research Institute
🇺🇸Oklahoma City, Oklahoma, United States
Tallaght Adult Mental Health Services
🇮🇪Dublin, Ireland
Cedar Clinical Research
🇺🇸Murray, Utah, United States
La Nua Day Hospital Mental Health Centre
🇮🇪Galway, Ireland
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