An Evaluation of the Long-Term Safety and Efficacy of TSND-201 for the Treatment of PTSD

Enrolling by invitation · Phase 3

Conditions studied: Post Traumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT07670702

Run by

Transcend Therapeutics

People needed

300

Starts

2026-06-01

Expected to finish

2029-01-01

Last updated by the study team

2026-06-26

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completion of a double-blind Transcend-sponsored clinical trial with TSND-201 (e.g., TSND201-PTSD-301) and considered in good standing with the study site.
• Proficient in communication (verbal and reading) to complete interviews and written questionnaires.
• Agree to not participate in any other interventional clinical trials for the duration of this study.

You may not qualify if…

• Experienced an intolerable side effect following dosing with TSND-201 in the prior study.
• Had significant deviation(s)/non-compliance in parent study in the opinion of the Investigator which would deem them unsuitable for participation.
• Change or development of any physical or psychological finding that would make participant unsuitable for study.

Where it is running

• CNS Healthcare — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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