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Orexin Antagonism for Suicide Risk: A Proof-of-Concept Clinical Trial
Sponsor: Marianne Goodman
Summary
The goal of this proof-of-concept clinical trial is to evaluate the initial safety, feasibility, and tolerability of the orexin mixed antagonist suvorexant in a sample of veteran adults with Major Depressive Disorder and elevated suicide risk. The main question it aims to answer is: Is Suvorexant safe, feasible, and tolerable for participants? Participants will: * Take Surovexant every day for four weeks (10mg in the first two weeks and 20mg in the second two weeks) * Visit the medical center at the beginning of the study (week 1), after taking Suvorexant for two weeks (week 3) and following the full Suvorexant dose (week 5) for in-person assessments. * Fill out self-report assessments (remotely) at week 2 (after one week of Suvorexant) and week 4 (after three weeks of Surovexant)
Official title: Orexin Antagonism to Target Mechanisms of Suicide Risk: A Proof-of-Concept Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-09-01
Completion Date
2027-07-01
Last Updated
2025-09-25
Healthy Volunteers
No
Interventions
Suvorexant (dual orexin receptor antagonist)
Veteran patients with Major Depressive Disorder and elevated risk of suicide will receive the FDA-approved drug Suvorexant (brand name: Belsomra), a dual orexin receptor antagonist, for four weeks. Participants will take 10mg of Surovexant nightly for the first two weeks and 20mg of Surovexant nightly for the second two weeks.
Locations (1)
James J. Peters Veterans Affairs Medical Center
The Bronx, New York, United States