An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD

Transcend Therapeutics62 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Post Traumatic Stress Disorder

Interventions

MethyloneDRUG

Methylone capsules, given orally, once a week for 3 weeks (Part A) or 4 weeks (Part B)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (12)

Segal Trials

Lauderhill, Florida, United States

Accel Research

Maitland, Florida, United States

CNS Healthcare

Orlando, Florida, United States

Outcomes

Primary Outcomes

Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score

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.