NCT07836647PHASE3Recruiting
An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
Transcend Therapeutics
Start Date
9/1/2026
Completion Date
2/1/2028
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
Age Range: 18 years to No maximum
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) \<18kg/m2 or ≥40 kg/m2.
* Unable to refrain from nicotine use for at least 8 hours.
* Use of prohibited concomitant medications or therapies.
* Current or previous history of clinically significant cardiovascular (including current uncontrolled hypertension) / cerebrovascular conditions.
Interventions
DRUG
TSND-201
DRUG
Placebo
Conditions
Post Traumatic Stress Disorder
Locations
Mountain View Clinical Research
Denver, Colorado 80209
United States
Bradenton Research Center
Bradenton, Florida 34205
United States