Suvorexant (an orexin blocker) for suicide risk in veterans with major depressive disorder
Official title: Orexin Antagonism to Target Mechanisms of Suicide Risk: A Proof-of-Concept Clinical Trial
Run by Bronx Veterans Medical Research Foundation, Inc · NCT06854224 · Data updated 2026-11-12
This trial will try daily suvorexant for four weeks to see if it is safe and tolerable for veterans with major depressive disorder who have had suicidal thoughts or attempts.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Bronx Veterans Medical Research Foundation, Inc Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | July 1, 2027 |
| Study ends | July 1, 2027 |
| Registry record updated | September 25, 2025 |
| Trial ID | NCT06854224 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are veteran adults aged 18–70 with a primary diagnosis of major depressive disorder and a history of suicide attempt plus current suicidal ideation (C-SSRS score ≥2) who are medically stable and not taking contraindicated medications.
✕Probably not a fit
Patients with active substance use disorder, bipolar or psychotic disorders, severe medical or neurological conditions, pregnancy or breastfeeding, or who need contraindicated medications are unlikely to qualify or benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 2, proof-of-concept interventional trial testing the orexin antagonist suvorexant in veteran adults with major depressive disorder and elevated suicide risk. Participants take 10 mg nightly for the first two weeks and 20 mg nightly for the second two weeks, with in-person visits at baseline, week 3, and week 5 and remote self-report assessments at weeks 2 and 4. The primary focus is on initial safety, feasibility, and tolerability of daily suvorexant in this population. The trial excludes people with certain medical, substance use, or psychiatric conditions that could confound safety or interpretation.
Why it matters
Potential benefit: If successful, this could identify a potentially safe short-term medication approach that might help address sleep-related drivers of suicidal thoughts in veterans with depression.
How similar studies have gone: Orexin antagonists like suvorexant are approved for insomnia and have an established safety profile for sleep, but using them specifically to reduce suicide risk is largely novel and has limited prior evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Veteran * At least 18 years of age (up to 70 years) * Primary diagnosis of Major Depressive Disorder as determined by the study psychiatrist and confirmed by the Mini-International Neuropsychiatric Interview (MINI) * Lifetime suicide attempt history and suicidal ideation at baseline as determined by a score ≥2 on the Columbia-Suicide Severity Rating Scale (C-SSRS) Exclusion Criteria: * Clinically significant medical or neurological condition * Current use of strong CYP3A live enzymes or 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 in the last six months, disorder, or current or past psychotic disorder, bipolar disorder, or obsessive-compulsive disorder * Severe traumatic brain injury * Imminent suicidal or homicidal risk * Free of unstable medical conditions or any contraindication to suvorexant (per FDA prescribing label) as determined by patient interview and review of available medical records.
Where it's running
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James J. Peters Veterans Affairs Medical Center
The Bronx, New York, United States Recruiting
Study contacts
- Study coordinator: Marianne Goodman, MD
- Email: Marianne.Goodman@va.gov
- Phone: 718-584-9000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.