A Study to Assess the Use of Methylone in the Treatment of PTSD (IMPACT-1)

Transcend Therapeutics

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Post Traumatic Stress Disorder

Treatments

Drug: Methylone

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05741710

TT-TSND-201

Details and patient eligibility

About

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.

Enrollment

79 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.