A Phase 1 interventional study of Methylone and Placebo in Post Traumatic Stress Disorder, sponsored by Transcend Therapeutics. Completed at 1 site in Australia. Open to participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by Transcend Therapeutics (part of Otsuka Holdings Co., Ltd.) · Phase 1, Interventional, and Treatment
This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's enrollment of 40 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Transcend Therapeutics is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
First submitted before Transcend Therapeutics became part of Otsuka Holdings Co., Ltd..
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
50 mg x 1 dose
Drug: Methylone
100 mg x 1 dose
Drug: Methylone
150 mg x 1 dose
Drug: Methylone
200 mg x 1 dose
Drug: Methylone
150 mg + 100 mg x 1
Drug: Methylone · Drug: Placebo
Oral dose of methylone
Placebo to match methylone
Cmax: Maximum Observed Plasma Concentration for methylone
Time frame: 48 hours following the dose
AUC: Area under the plasma concentration-time curve for methylone
Time frame: 48 hours following the dose
Incidence and frequency of adverse events
Time frame: 10 days after the dose
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2024 to primary completion in Jul 2025, 15 months.
Of 52 phase 1 interventional studies under Stress Disorders, Post-Traumatic, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 54. This study's 15 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methylone
Stress Disorders, Post-Traumatic →