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

Description

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).

Conditions

Post Traumatic Stress Disorder
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Related Conditions:

Post Traumatic Stress Disorder

Study Overview

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Study Details

Study 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).

An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD IMPACT-2 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])

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

Condition
Post Traumatic Stress Disorder
Intervention / Treatment

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Contacts and Locations

Lauderhill

Segal Trials, Lauderhill, Florida, United States, 33319

Orlando

CNS Healthcare, Orlando, Florida, United States, 32801

Chicago

Uptown Clinical Research, Chicago, Illinois, United States, 60640

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Meets DSM-5 criteria for severe PTSD diagnosis, with a symptom duration of at least 6 months.
  • * CAPS-5 score of at least 35 at Screening.
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Transcend Therapeutics,

Study Record Dates

2025-12