Status:
COMPLETED
An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD
Lead Sponsor:
Transcend Therapeutics
Conditions:
Post Traumatic Stress Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2025
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06215261
Start Date
April 4 2024
End Date
September 23 2025
Last Update
November 25 2025
Active Locations (12)
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1
Segal Trials
Lauderhill, Florida, United States, 33319
2
Accel Research
Maitland, Florida, United States, 32751
3
CNS Healthcare
Orlando, Florida, United States, 32801
4
Uptown Clinical Research
Chicago, Illinois, United States, 60640