A Study to Assess the Use of Methylone in the Treatment of Post-Traumatic Stress Disorder (PTSD)
- Conditions
- Post-Traumatic Stress Disorder (PTSD)MedDRA version: 21.1Level: PTClassification code: 10036316Term: Post-traumatic stress disorder Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- CTIS2023-505874-14-00
- Lead Sponsor
- Transcend Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- 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. (The PTSD diagnosis will be confirmed at Baseline by the central rater)., CAPS-5 score of ‚ =35 at Screening and =28 at Baseline., 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method