Post Traumatic Stress Disorder
Conditions
Keywords
methylone, PTSD, IMPACT-1, 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.
Interventions
DRUGMethylone
Methylone capsules, given orally, once a week for 4 weeks
DRUGPlacebo
Placebo capsules to match methylone, given orally, once a week for 4 weeks. NOTE: Placebo is only in Part B
Sponsors
Transcend Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| Incidence of treatment-emergent adverse events (TEAEs) | up to 10 weeks | Type and rates of adverse events |
Countries
Ireland, United Kingdom, United States
Outcome results
None listed