A Study to Assess the Use of Methylone in the Treatment of PTSD

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study to Assess the Use of Methylone in the Treatment of PTSD IMPACT-1 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Drug: Methylone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylone<br> | Drug: Methylone<br>* Methylone capsules, given orally, once a week for 4 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo capsules to match methylone, given orally, once a week for 4 weeks. NOTE: Placebo is only in Part B<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score | 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. | up to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score | 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. | up to 10 weeks | 
| Change from Baseline in PTSD Checklist for DSM-5 (PCL-5) | 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. | up to 10 weeks | 
| Change from Baseline in Sheehan Disability Scale (SDS) | 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. | up to 10 weeks | 
| Incidence of treatment-emergent adverse events (TEAEs) | Type and rates of adverse events | up to 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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methylone, PTSD, IMPACT-1, Transcend Therapeutics