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])

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06237426

Acronym

IMPACT-EXT

Enrollment

Registered

2024-02-01

Start date

2024-03-06

Completion date

2025-10-06

Last updated

2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Stress Disorder

Keywords

PTSD, IMPACT-EXT, Methylone, Neuroplastogen, Transcend Therapeutics, TSND-201

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.

Interventions

DRUGMethylone

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 71 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in Clinician Administered PTSD Scale for DSM-5 (CAPS-5) total severity score	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

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

Countries

Ireland, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026