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

March 30, 2026 updated by: Transcend Therapeutics

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])

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
        • Tallaght Adult Mental Health Services
      • Galway, Ireland
        • La Nua Day Hospital Mental Health Centre
  • United Kingdom
      • Cambridge, United Kingdom
        • Cambridge University Hospitals NHS Foundation Trust
      • Glasgow, United Kingdom
        • Glasgow Clinical Research Facility, QEUH
      • London, United Kingdom
        • King's College
      • London, United Kingdom
        • Clerkenwell Health
      • Oxford, United Kingdom
        • Oxford Health NHS Foundation Trust
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom
        • Mirabilis Health
  • United States
    • Colorado
      • Denver, Colorado, United States, 80209
        • Mountain View Clinical Research
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions - Jacksonville
      • Maitland, Florida, United States, 32751
        • Accel Research Sites
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Sunstone Therapies
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Boston Clinical Trials
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • CenExel HRI
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • The Rivus Wellness & Research Institute
    • Utah
      • Murray, Utah, United States, 84107
        • Cedar Clinical Research

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in 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.
up to 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 10 weeks
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.
up to 10 weeks
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.
up to 10 weeks
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: up to 10 weeks
Type and rates of adverse events
up to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Transcend Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

February 19, 2025

Study Completion (Actual)

February 19, 2025

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Actual)

February 23, 2023

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TT-TSND-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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