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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-06

Study Completion Date

2025-10-06

Brief Summary

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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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Detailed Description

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Conditions

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Post Traumatic Stress Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (Methylone)

Group Type EXPERIMENTAL

Methylone

Intervention Type DRUG

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

Interventions

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Methylone

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

71 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No