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

RecruitingPhase 3

Sponsor: Transcend Therapeutics

Conditions: Post Traumatic Stress Disorder

Interventions: TSND-201, Placebo

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (32)

Tucson, Arizona, United States
Little Rock, Arkansas, United States
La Jolla, California, United States
Los Angeles, California, United States
Montclair, California, United States
Oceanside, California, United States
Orange, California, United States
San Juan Capistrano, California, United States
Evergreen, Colorado, United States
Jacksonville, Florida, United States
Lauderhill, Florida, United States
Maitland, Florida, United States
Orlando, Florida, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Pikesville, Maryland, United States
Worcester, Massachusetts, United States
Creve Coeur, Missouri, United States
Saint Charles, Missouri, United States
Cherry Hill, New Jersey, United States
Princeton, New Jersey, United States
Toms River, New Jersey, United States
New York, New York, United States
Independence, Ohio, United States
Plymouth Meeting, Pennsylvania, United States
West Chester, Pennsylvania, United States
Austin, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
Draper, Utah, United States
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