An Evaluation of the Long-term Efficacy and Safety of Methylone for the Treatment of PTSD (IMPACT-EXT)

November 19, 2025 updated by: Transcend Therapeutics

A 52-Week, Open-Label Evaluation of the Long-term Efficacy and Safety of Single and Repeated Treatments With Methylone for the Treatment of PTSD IMPACT-EXT (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])

This is an extension study of participants who previously completed a Transcend-sponsored clinical trial evaluating TSND-201 as a treatment for PTSD.

Participants will be followed for up to 52 weeks. During the 52 week period, PTSD symptoms and safety will be assessed monthly.

Participants' PTSD symptoms will be assessed at each observational visit and if criteria for Relapse has been met, participants may be eligible to receive a course of TSND-201 treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

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
      • Galway, Ireland
        • La Nua Mental Health Centre
  • United Kingdom
      • London, United Kingdom
        • Kings College
      • London, United Kingdom
        • Clerkenwell Health
    • England
      • Cambridge, England, United Kingdom
        • Cambridgeshire and Peterborough NHS Foundation Trust
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom
        • Mirabilis Health
    • Scotland
      • Glasgow, Scotland, United Kingdom
        • NHS Greater Glasgow and Clyde
  • United States
    • Colorado
      • Denver, Colorado, United States, 80209
        • Mountain View Clinical Research
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Sunstone Medical
    • Utah
      • Draper, Utah, United States, 84020
        • Cedar Clinical Research, Inc

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participation in and successful completion of a prior Transcend-sponsored clinical trial with TSND-201.
  • Agree to not participate in any other interventional clinical trials for the duration of this study.
  • Willing and able to provide informed consent.

Exclusion Criteria:

  • Had significant deviation(s)/non-compliance in parent study in the opinion of the Investigator which would deem them unsuitable for participation.
  • Change or development of any physical or psychological finding that would make participant unsuitable for study.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (Methylone)
Drug: Methylone
A course of treatment includes 4 weekly doses of TSND-201.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Clinician Administered PTSD Scale for DSM-5 (CAPS-5) total severity score
Time Frame: Up to 52 weeks
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.
Up to 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of serious adverse events (SAEs), adverse events of special interest (AESIs), and treatment-emergent adverse events (TEAEs)
Time Frame: Up to 52 weeks
Types and rates of adverse events
Up to 52 weeks

Collaborators and Investigators

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

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 Major Dates

Study Start (Actual)

March 6, 2024

Primary Completion (Actual)

October 6, 2025

Study Completion (Actual)

October 6, 2025

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSND201-PTSD-203

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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