A Phase 3 interventional study of TSND-201 in Post Traumatic Stress Disorder, sponsored by Transcend Therapeutics. Enrolling by invitation at 17 sites in United States. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Transcend Therapeutics (part of Otsuka Holdings Co., Ltd.) · Phase 3, Interventional, and Treatment
This study is evaluating the long-term safety and efficacy of TSND-201 in adults with PTSD. Participants that have completed a double-blind clinical trial with TNSD-201 for PTSD will be invited to participate in this open-label extension trial.
Each participant will be able to receive up to three Treatment Courses over the duration of the study (up to 48 weeks). Each Treatment Course includes 4 dosing sessions, spaced one week apart.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 300 is above 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.
Unclear whether first submitted before or after 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:
Drug: TSND-201
TSND-201 capsules, given orally; where a course of treatment includes dosing with TSND-201 once a week for four consecutive weeks
Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
CAPS-5 is a structured interview designed to assess PTSD symptoms severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.
Time frame: Up to 48 weeks
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: TSND-201
Stress Disorders, Post-Traumatic →