Phase 2 N=79 Randomized Triple-blind Treatment

A Study to Assess the Use of Methylone in the Treatment of PTSD

Post Traumatic Stress Disorder

Bottom Line

View on ClinicalTrials.gov: NCT05741710 ↗

Enrolled (actual)

Serious AEs

1.3%

Results posted

Apr 2026

Primary outcome: Primary: Change From Baseline in CAPS-5 Total Severity Score — -36.2; -23.3; -13.6 points — p=0.011

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Methylone (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Transcend Therapeutics
Primary completion: Feb 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in CAPS-5 Total Severity Score	-36.2; -23.3; -13.6	0.011 sig

Summary

This study is evaluating the safety, tolerability, and efficacy of methylone in adults with PTSD. The study will be conducted in two parts. * Part A is open-label and will enroll up to 15 participants with PTSD * Part B is randomized (1:1), double-blind, placebo-controlled and will enroll up to 64 participants with PTSD Eligible participants will enter a 4-week Treatment Period where they will receive methylone once weekly for 4 weeks (4 treatment sessions). Following the Treatment Period, participants will enter a 6-week Follow-up Period which includes 3 reflection visits (Week 4, 5, and 6) and a final study visit at Week 10.

Eligibility Criteria

Inclusion Criteria

Meets the DSM-5 criteria for current moderate to severe PTSD diagnosis, with a symptom duration of at least 6 months
CAPS-5 score of ≥35 at Screening.
Failed at least one treatment for PTSD (either psychotherapy or pharmacological treatment).
Proficient in reading and writing in local language sufficient to complete questionnaires.
Free from any other clinically significant illness or disease

Exclusion Criteria

Primary diagnosis of any other DSM-5 disorder
Body mass index (BMI) 10 cigarettes and/or e-cigarettes per day
Uncontrolled hypertension at Screening
Use of a psychedelic (e.g., LSD, psilocybin, DMT, mescaline), or entactogens such as MDMA, within 12 months of Screening.
Use of an SSRI or other antidepressant within 8 weeks of screening.
Current or previous history of clinically significant cardiovascular/cerebrovascular conditions.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05741710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.