An Evaluation of the Long-term Efficacy and Safety of Methylone for the Treatment of PTSD
IMPACT-EXT
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])
1 other identifier
interventional
44
3 countries
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2024
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2024
CompletedFirst Posted
Study publicly available on registry
February 1, 2024
CompletedStudy Start
First participant enrolled
March 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2025
CompletedNovember 25, 2025
November 1, 2025
1.6 years
January 23, 2024
November 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in Clinician Administered PTSD Scale for DSM-5 (CAPS-5) total severity score
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 Outcomes (1)
Incidence of serious adverse events (SAEs), adverse events of special interest (AESIs), and treatment-emergent adverse events (TEAEs)
Up to 52 weeks
Study Arms (1)
Treatment (Methylone)
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Mountain View Clinical Research
Denver, Colorado, 80209, United States
Sunstone Medical
Rockville, Maryland, 20850, United States
Cedar Clinical Research, Inc
Draper, Utah, 84020, United States
La Nua Mental Health Centre
Galway, Ireland
Cambridgeshire and Peterborough NHS Foundation Trust
Cambridge, England, United Kingdom
Mirabilis Health
Belfast, Northern Ireland, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, Scotland, United Kingdom
Clerkenwell Health
London, United Kingdom
Kings College
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2024
First Posted
February 1, 2024
Study Start
March 6, 2024
Primary Completion
October 6, 2025
Study Completion
October 6, 2025
Last Updated
November 25, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share