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Completed

NCT Number: NCT06237426

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

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–71 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

La Nua Mental Health Centre, Galway, Ireland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Methylone

Drug

A course of treatment includes 4 weekly doses of TSND-201.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Transcend Therapeutics

Industry

Registry information

Official study title

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])

Acronym: IMPACT-EXT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 1, 2024
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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