Actively Recruiting
Orexin Antagonism for Suicide Risk: A Proof-of-Concept Clinical Trial
Led by Marianne Goodman · Updated on 2025-09-25
30
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
Sponsors
M
Marianne Goodman
Lead Sponsor
J
James J. Peters Veterans Affairs Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Orexin Antagonism for Suicide Risk: A Proof-of-Concept Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veteran
- Between 18 and 70 years old
- Primary diagnosis of Major Depressive Disorder confirmed by study psychiatrist and Mini-International Neuropsychiatric Interview (MINI)
- History of suicide attempt and suicidal ideation at baseline with a score of 2 or higher on the Columbia-Suicide Severity Rating Scale (C-SSRS)
You will not qualify if you...
- Clinically significant medical or neurological condition
- Current use of strong CYP3A live enzymes, moderate CYP3A inhibitors, or strong CYP3A inducers
- Current use of digoxin
- Currently pregnant, not using contraception, nursing, or trying to become pregnant
- Active substance use disorder within the last six months
- Current or past psychotic disorder, bipolar disorder, or obsessive-compulsive disorder
- Severe traumatic brain injury
- Imminent suicidal or homicidal risk
- Unstable medical conditions or contraindication to suvorexant as determined by medical review
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
James J. Peters Veterans Affairs Medical Center
The Bronx, New York, United States, 10468
Actively Recruiting
Research Team
M
Marianne Goodman, MD
CONTACT
J
James Murrough, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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