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Orexin Antagonism for Suicide Risk: A Proof-of-Concept Clinical Trial

Orexin Antagonism to Target Mechanisms of Suicide Risk: A Proof-of-Concept Clinical Trial

Who can join

Ages 18 to 70 · All sexes

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.

About the study

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)

What is being tested

• Suvorexant (dual orexin receptor antagonist) (drug)

Sponsor: Marianne Goodman · Participants: 30 · Started: Sep 1, 2025

Contact the study team

• Marianne Goodman, MD · Phone: 718-584-9000
• James Murrough, MD, PhD · Phone: 212-585-4640

Official record on ClinicalTrials.gov — NCT06854224

Locations in the U.S.

Conditions

• Major Depressive Disorder

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.