150 Participants Needed

Methylone for PTSD

(IMPACT-EXT Trial)

Recruiting at 8 trial locations
SD
Overseen ByStudy Director
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Transcend Therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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?

Methylone has shown significant benefits in a clinical case series of PTSD patients and was well-tolerated in early studies. Additionally, similar drugs like MDMA have demonstrated substantial improvements in PTSD treatment, suggesting potential effectiveness for Methylone.12345

Is Methylone safe for human use?

Methylone was well-tolerated in two Phase 1 studies involving healthy volunteers, suggesting it may be generally safe for human use.14678

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants may receive a course of TSND-201 treatment if criteria for relapse are met

Variable
As needed based on relapse criteria

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks
Monthly visits

Open-label extension

Long-term evaluation of the efficacy and safety of Methylone for PTSD

52 weeks

Treatment Details

Interventions

  • Methylone
Trial Overview 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (Methylone)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Transcend Therapeutics

Lead Sponsor

Trials
4
Recruited
310+

Findings from Research

Methylone demonstrated rapid and significant antidepressant-like effects in preclinical tests, reducing immobility by nearly 95% in the Forced Swim Test, with effects lasting at least 72 hours after a single dose, which is much more effective than the SSRI fluoxetine.
In addition to its antidepressant effects, methylone also showed anxiolytic properties, suggesting it may be beneficial for treating both depression and anxiety, potentially offering a faster-acting alternative to traditional SSRIs.
Methylone, a rapid acting entactogen with robust anxiolytic and antidepressant-like activity.Warner-Schmidt, J., Pittenger, C., Stogniew, M., et al.[2023]
MDMA-assisted psychotherapy has received Breakthrough Therapy Designation from the FDA for treating PTSD, showing a large effect size in pooled analyses, which suggests it may be significantly more effective than traditional medications like paroxetine and sertraline.
The treatment involves MDMA administered in a controlled setting with psychotherapy, resulting in lower dropout rates and minimal risks of overdose or withdrawal symptoms, indicating a safer profile compared to conventional pharmacotherapies.
Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline.Feduccia, AA., Jerome, L., Yazar-Klosinski, B., et al.[2023]
MDMA-assisted psychotherapy has received Breakthrough Therapy Designation from the FDA for treating PTSD, showing a large effect size in studies compared to the small to moderate effects of traditional medications like paroxetine and sertraline.
This treatment approach, which involves MDMA administration during psychotherapy sessions, demonstrated better safety profiles and lower dropout rates than conventional antidepressants, with minimal risk of overdose or withdrawal symptoms.
Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline.Feduccia, AA., Jerome, L., Yazar-Klosinski, B., et al.[2020]

References

Methylone, a rapid acting entactogen with robust anxiolytic and antidepressant-like activity. [2023]
Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline. [2023]
Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline. [2020]
"Being with a Buddha": A Case Report of Methoxetamine Use in a United States Veteran with PTSD. [2020]
Treatment of posttraumatic stress disorder: the impact of paroxetine. [2022]
The potential of ketamine for posttraumatic stress disorder: a review of clinical evidence. [2023]
Pharmacological Management of Nightmares Associated with Posttraumatic Stress Disorder. [2022]
Pharmacologic alternatives to antidepressants in posttraumatic stress disorder: a systematic review. [2022]
The efficacy of memantine in the treatment of civilian posttraumatic stress disorder: an open-label trial. [2021]
SSRIs versus non-SSRIs in post-traumatic stress disorder: an update with recommendations. [2022]
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