Post Traumatic Stress Disorder
Conditions
Keywords
Methylone, IMPACT-2, PTSD, Neuroplastogen, TSND-201
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 is randomized (1:1:1), single-blind and will enroll up to 45 participants with PTSD Eligible participants will enter a 3-week Treatment Period (Part A) or 4-week Treatment Period (Part B) where they will receive methylone once weekly. Following the Treatment Period, participants will enter a 6-week Follow-up Period (Part A) or 8-week Follow-up Period (Part B).
Interventions
DRUGMethylone
Methylone capsules, given orally, once a week for 3 weeks (Part A) or 4 weeks (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 70 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) Total Severity Score | 9 weeks (Part A) / 12 weeks (Part B) | The CAPS-5 is a structured interview designed to assess PTSD symptom 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 | 9 weeks (Part A) / 12 weeks (Part B) | 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) | 9 weeks (Part A) / 12 weeks (Part B) | 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) | 9 weeks (Part A) / 12 weeks (Part B) | 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 representing greater disability. Total scores range from 0 to 30, with higher scores representing greater disability. |
| Incidence of Treatment-emergent Adverse Events (TEAEs) | 9 weeks (Part A) / 12 weeks (Part B) | Types and rates of adverse events (Results are presented in the Adverse Events section) |
Countries
Australia, United Kingdom, United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 44.5 Years STANDARD_DEVIATION 10.37 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 47 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 17 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 15 / 15 | 17 / 17 | 14 / 15 | 14 / 15 |
| serious Total, serious adverse events | 1 / 15 | 0 / 17 | 0 / 15 | 0 / 15 |
Outcome results
None listed