Methylone for PTSD
(IMPACT-EXT Trial)
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Methylone for PTSD?
Is Methylone safe for human use?
How does the drug Methylone differ from other PTSD treatments?
Methylone is unique because it acts rapidly as an entactogen, providing quick relief from PTSD symptoms, unlike traditional SSRIs which can take weeks to show effects. It has shown significant benefits in early studies and is well-tolerated, offering a novel approach compared to the delayed onset and side effects associated with SSRIs.124910
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants may receive a course of TSND-201 treatment if criteria for relapse are met
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Long-term evaluation of the efficacy and safety of Methylone for PTSD
Treatment Details
Interventions
- Methylone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Transcend Therapeutics
Lead Sponsor