Orexin Antagonism for Suicide Risk: A Proof-of-Concept Clinical Trial
Recruiting · NCT06854224 · Interventional (participants receive a specific treatment) · Lead sponsor: Marianne Goodman
View the official record on ClinicalTrials.gov →Interventions studied
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)
Who can take part
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 is running
1 location listed across 1 US state.
- James J. Peters Veterans Affairs Medical Center - The Bronx, New York, United States