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.
Transcend Therapeutics
Lead sponsor