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An Evaluation of the Long-term Efficacy and Safety of Methylone for the Treatment of PTSD | Clinical Trials | Clareo Health

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An Evaluation of the Long-term Efficacy and Safety of Methylone for the Treatment of PTSD

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])

NCT06237426•Transcend Therapeutics

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 71 years

Sex

ALL

Healthy Volunteers

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.

Locations (9)

Mountain View Clinical Research

Denver, Colorado, United States

Sunstone Medical

Rockville, Maryland, United States

Cedar Clinical Research, Inc

Draper, Utah, 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

Key Dates

Start Date

March 6, 2024

Primary Completion Date

October 6, 2025

Completion Date

October 6, 2025

Last Updated

November 25, 2025

Enrollment

ACTUAL participants

Conditions

Post Traumatic Stress Disorder

Interventions

Methylone

DRUG

Stepped Care for Posttraumatic Stress Disorder Study

NCT06947538

Post Traumatic Stress Disorder

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RECRUITINGNA

Digital Biofeedback for Combat Veterans Diagnosed With PTSD

NCT07462312

PTSD - Post Traumatic Stress Disorder

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RECRUITINGNA

A Pilot Study of Trauma-Focused Cognitive-Behavioral Therapy for Treatment of Post-traumatic Stress in Adults.

NCT06516874

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Evaluation of the Long-term Efficacy and Safety of Methylone for the Treatment of PTSD

Inclusion Criteria

Exclusion Criteria

Stepped Care for Posttraumatic Stress Disorder Study

Digital Biofeedback for Combat Veterans Diagnosed With PTSD

A Pilot Study of Trauma-Focused Cognitive-Behavioral Therapy for Treatment of Post-traumatic Stress in Adults.

Advanced Wireless Augmented Reality-Enhanced Exposure Therapy for Posttraumatic Stress Disorder

Development of the PTSD-iMPACT to Measure PTSD-Related Functional Impairment in Children and Adolescents - A Validation Study in Switzerland and Germany

Transcranial Magnetic Stimulation in Veterans With PTSD