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Methylone for PTSD (IMPACT-1 Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Transcend Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meets the DSM-5 criteria for current moderate to severe PTSD diagnosis, with a symptom duration of at least 6 months
Failed at least one treatment for PTSD (either psychotherapy or pharmacological treatment).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 weeks

Summary

This trial is testing the safety, side effects, and effectiveness of methylone in adults with PTSD. The study has two parts: Part A will include up to 15 participants and is open-label,

Who is the study for?
This trial is for adults with moderate to severe PTSD, who have struggled with symptoms for at least 6 months and haven't improved after trying a treatment. Participants must be able to read and write in the local language and not have other serious illnesses.
What is being tested?
The study tests Methylone's safety and effectiveness for PTSD in two parts: an initial open-label phase where up to 15 participants know they're getting Methylone, followed by a double-blind phase where neither the researchers nor up to 64 participants know if they're receiving Methylone or a placebo.
What are the potential side effects?
While specific side effects of Methylone are not listed here, common concerns may include potential mood changes, anxiety, sleep disturbances, or physical reactions like headaches or nausea. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with moderate to severe PTSD for at least 6 months.
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I have tried at least one treatment for PTSD that didn't work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score
Secondary study objectives
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score
Change from Baseline in PTSD Checklist for DSM-5 (PCL-5)
Change from Baseline in Sheehan Disability Scale (SDS)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MethyloneExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

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Who is running the clinical trial?

Transcend TherapeuticsLead Sponsor
3 Previous Clinical Trials
253 Total Patients Enrolled
~28 spots leftby Jan 2026
Unbiased ResultsWe believe in providing patients with all the options.
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