A Study to Assess the Use of Methylone in the Treatment of PTSD
- Conditions
- Post Traumatic Stress Disorder
- Registration Number
- NCT05741710
- Lead Sponsor
- Transcend Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Meets the DSM-5 criteria for current moderate to severe PTSD diagnosis, with a<br> symptom duration of at least 6 months<br><br> - CAPS-5 score of =35 at Screening.<br><br> - Failed at least one treatment for PTSD (either psychotherapy or pharmacological<br> treatment).<br><br> - Proficient in reading and writing in local language sufficient to complete<br> questionnaires.<br><br> - Free from any other clinically significant illness or disease<br><br>Exclusion Criteria:<br><br> - Primary diagnosis of any other DSM-5 disorder<br><br> - Body mass index (BMI) <18 kg/m2 or =40 kg/m2.<br><br> - Smokes an average of >10 cigarettes and/or e-cigarettes per day<br><br> - Uncontrolled hypertension at Screening<br><br> - Use of a psychedelic (e.g., LSD, psilocybin, DMT, mescaline), or entactogens such as<br> MDMA, within 12 months of Screening.<br><br> - Use of an SSRI or other antidepressant within 8 weeks of screening.<br><br> - Current or previous history of clinically significant cardiovascular/cerebrovascular<br> conditions.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score
- Secondary Outcome Measures
Name Time Method Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score;Change from Baseline in PTSD Checklist for DSM-5 (PCL-5);Change from Baseline in Sheehan Disability Scale (SDS);Incidence of treatment-emergent adverse events (TEAEs)