COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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])

Quick Facts

Study Start:2024-04-04
Study Completion:2025-09-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06215261

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Meets DSM-5 criteria for severe PTSD diagnosis, with a symptom duration of at least 6 months.
  2. * Tried at least one treatment for PTSD (either psychotherapy or pharmacological treatment).
  3. * Proficient in reading and writing in local language sufficient to complete questionnaires.
  4. * Free from any other clinically significant illness or disease.
  1. * Primary diagnosis of any other DSM-5 disorder.
  2. * Body mass index (BMI) \<18kg/m2 or ≥40 kg/m2.
  3. * Smokes an average of \>10 cigarettes and/or e-cigarettes per day.
  4. * Uncontrolled hypertension at Screening.
  5. * Use of prohibited concomitant medications or therapies.
  6. * Current or previous history of clinically significant cardiovascular/cerebrovascular conditions.

Contacts and Locations

Study Locations (Sites)

Segal Trials
Lauderhill, Florida, 33319
United States
Accel Research
Maitland, Florida, 32751
United States
CNS Healthcare
Orlando, Florida, 32801
United States
Uptown Clinical Research
Chicago, Illinois, 60640
United States
Sunstone Medical
Rockville, Maryland, 20850
United States
Redbird Research LLC
Las Vegas, Nevada, 89119
United States
Numinus
Draper, Utah, 84020
United States
Seattle NTC
Bellevue, Washington, 98004
United States

Collaborators and Investigators

Sponsor: Transcend Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-04
Study Completion Date2025-09-23

Study Record Updates

Study Start Date2024-04-04
Study Completion Date2025-09-23

Terms related to this study

Keywords Provided by Researchers

  • Methylone
  • IMPACT-2
  • PTSD
  • Neuroplastogen
  • TSND-201

Additional Relevant MeSH Terms

  • Post Traumatic Stress Disorder