A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
Transcend Therapeutics
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * 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 medication…
Interventions
- DrugTSND-201
TSND-201 capsules, given orally, once a week for four consecutive weeks
- DrugPlacebo
Placebo capsules, given orally, once a week for four consecutive weeks
Locations (19)
- Preferred Research PartnersLittle Rock, Arkansas
- CalNeuro Research GroupLos Angeles, California
- Catalina Research InstituteMontclair, California
- Inland Psychiatric Medical GroupSan Juan Capistrano, California
- Starlight Clinical ResearchEvergreen, Colorado
- CNS HealthcareJacksonville, Florida