Age

18–any

Sex

ALL

Healthy volunteers

Not accepted

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.
Current or previous history of clinically significant cardiovascular (including current uncontrolled hypertension) / cerebrovascular conditions.

An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-1)