The classic website will no longer be available as of June 25, 2024. Please use the modernized
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05741710
Recruitment Status : Recruiting
First Posted : February 23, 2023
Last Update Posted : June 11, 2024
Information provided by (Responsible Party):
Transcend Therapeutics

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Drug: Methylone Drug: Placebo Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study to Assess the Use of Methylone in the Treatment of PTSD IMPACT-1 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])
Actual Study Start Date : March 1, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Methylone Drug: Methylone
Methylone capsules, given orally, once a week for 4 weeks

Placebo Comparator: Placebo Drug: Placebo
Placebo capsules to match methylone, given orally, once a week for 4 weeks. NOTE: Placebo is only in Part B

Primary Outcome Measures :
  1. Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score [ Time Frame: up to 10 weeks ]
    CAPS-5 is a structured interview designed to assess PTSD symptoms severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.

Secondary Outcome Measures :
  1. Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score [ Time Frame: up to 10 weeks ]
    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.

  2. Change from Baseline in PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: up to 10 weeks ]
    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.

  3. Change from Baseline in Sheehan Disability Scale (SDS) [ Time Frame: up to 10 weeks ]
    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 represented more disability. Total sores range from 0 to 30.

  4. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: up to 10 weeks ]
    Type and rates of adverse events

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05741710

Layout table for location contacts
Contact: Study Director 650-769-6472

Layout table for location information
Tallaght Adult Mental Health Services Recruiting
Dublin, Ireland
La Nua Day Hospital Mental Health Centre Recruiting
Galway, Ireland
United Kingdom
Mirabilis Health Recruiting
Belfast, Northern Ireland, United Kingdom
Cambridge University Hospitals NHS Foundation Trust Not yet recruiting
Cambridge, United Kingdom
Contact: Maddie Smith   
Glasgow Clinical Research Facility, QEUH Recruiting
Glasgow, United Kingdom
Contact    0141 232 7599   
Clerkenwell Health Recruiting
London, United Kingdom
Contact: Study Coordinator    02038974860   
King's College Recruiting
London, United Kingdom
Contact: James Rucker, MD   
St. Pancras Clinical Research Recruiting
London, United Kingdom
Sponsors and Collaborators
Transcend Therapeutics
Layout table for additonal information
Responsible Party: Transcend Therapeutics Identifier: NCT05741710    
Other Study ID Numbers: TT-TSND-201
First Posted: February 23, 2023    Key Record Dates
Last Update Posted: June 11, 2024
Last Verified: June 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Transcend Therapeutics:
Transcend Therapeutics
Additional relevant MeSH terms:
Layout table for MeSH terms
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders