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.
Meets the 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.
Primary diagnosis of any other DSM-5 disorder.
Body mass index (BMI) <18 kg/m2 or ≥40 kg/m2.
Unable to refrain from nicotine use for at least 8 hours.
Use of prohibited concomitant medications or therapies.
Parallel
TSND-201
DrugTSND-201 capsules, given orally, once a week for four consecutive weeks
Placebo
DrugPlacebo capsules, given orally, 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.
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