Testing suvorexant for depression and suicide risk in veterans
Tests suvorexant, a sleep-related drug, in veterans with depression and high suicide risk.
Plain-language title generated from the registry record
Registry title: Orexin Antagonism for Suicide Risk: A Proof-of-Concept Clinical Trial
Key facts
- Where
- The Bronx, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06854224, who can take part
Where in United States
- James J. Peters Veterans Affairs Medical CenterThe Bronx, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Marianne Goodman
- Trial code
- NCT06854224
- Record updated
- 25 September 2025
- Original description
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?Read full original descriptionShow less
Orexin Antagonism to Target Mechanisms of Suicide Risk: A Proof-of-Concept Clinical Trial
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)
Inclusion: 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: Current use of strong CYP3A live enzymes or moderate CYP3A inhibitors or strong CYP3A inducers; Clinically significant medical or neurological condition; Active substance use disorder in the last six months, disorder, or current or past psychotic disorder, bipolar disorder, or obsessive-compulsive disorder; 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; Current use of digoxin; Currently pregnant, not using contraception, nursing, or trying to become pregnant; Severe traumatic brain injury; Imminent suicidal or homicidal risk.