A Phase 2 interventional study of Methylone in Post Traumatic Stress Disorder, sponsored by Transcend Therapeutics. Completed at 9 sites in 3 countries. Open to participants aged 18 Years to 71 Years. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Transcend Therapeutics (part of Otsuka Holdings Co., Ltd.) · Phase 2, Interventional, and Treatment
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.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's enrollment of 44 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Methylone
A course of treatment includes 4 weekly doses of TSND-201.
Change from baseline in Clinician Administered PTSD Scale for DSM-5 (CAPS-5) total severity score
The CAPS-5 is a structured interview designed to assess PTSD symptom severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.
Time frame: Up to 52 weeks
Incidence of serious adverse events (SAEs), adverse events of special interest (AESIs), and treatment-emergent adverse events (TEAEs)
Types and rates of adverse events
Time frame: Up to 52 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2024 to primary completion in Oct 2025, 19 months.
Of 31 industry-sponsored phase 2 interventional studies under Stress Disorders, Post-Traumatic, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 33. This study's 19 months is below that.
Counting every sponsor, half of 118 studies reached it within 38 months; a quarter within 23 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 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 →