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NCT07836647
An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
Conditions: Post Traumatic Stress Disorder
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 300
Sponsor: Transcend Therapeutics
Location: Mountain View Clinical Research Denver Colorado
Summary
This study is evaluating the safety and efficacy of TSND-201 in adults with PTSD. Eligible participants will enter a 4-week Treatment Period where they will be randomized 1:1:1 to receive one of two doses of TSND-201 or placebo, once per week. Following the Treatment Period, participants will enter an 8-week Follow-up Period.
Eligibility Criteria
Inclusion Criteria:
* Meets DSM-5 criteria for current PTSD diagnosis, with a symptom duration of at least 6 months.
* Tried at least one pharmacological treatment for PTSD or trauma-focused psychotherapy.
* Proficient in communication (verbal and reading) to complete interviews and written questionnaires.
* Free from any other clinically significant illness or disease.
Exclusion Criteria:
* Primary diagnosis of any other DSM-5 disorder.
* Body mass index (BMI) \
Source: ClinicalTrials.gov (NCT07836647). StuddyBuddy aggregates publicly available trial information.
