Methylone for PTSD
(IMPACT-EXT Trial)

Recruiting in Palo Alto (17 mi)

+8 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Transcend Therapeutics

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for individuals who have completed a previous Transcend-sponsored clinical trial using Methylone for PTSD. Participants must not join other trials during this study and should be able to give informed consent.

Inclusion Criteria

I have successfully completed a previous clinical trial with methylone sponsored by Transcend.

I am willing and able to understand and provide my consent for the trial.

I agree not to join any other clinical trials while I am part of this study.

Participant Groups

The study observes the long-term effects of Methylone on PTSD over 52 weeks, with monthly assessments. If participants relapse, they may receive TSND-201 treatment again.

1Treatment groups

Experimental Treatment

Group I: Treatment (Methylone)Experimental Treatment1 Intervention