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

Inclusion Criteria:

• Meets the DSM-5 criteria for current PTSD diagnosis, with a symptom duration of atleast 6 months.

• Tried at least one pharmacological treatment for PTSD or trauma-focusedpsychotherapy.

• Proficient in communication (verbal and reading) to complete interviews and writtenquestionnaires.

• 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 medications or therapies.

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