Recruiting
Phase 2

Suvorexant

Sponsor:

Marianne Goodman

Code:

NCT06854224

Conditions

Suicide Risk

Major Depressive Disorder (MDD)

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Suvorexant (dual orexin receptor antagonist)

Study Details

Brief summary:

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

Suicide Risk

Major Depressive Disorder (MDD)

Study ID

NCT06854224

Start date

Sep 1, 2025

Status verified date

Sep, 2025

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Suvorexant group

Veteran patients with Major Depressive Disorder and elevated risk of suicide will receive the FDA-approved drug Suvorexant (brand name: Belsomra), a mixed Orexin antagonist, for four weeks. Participants will take 10mg of Surovexant nightly for the first two weeks and 20mg of Surovexant nightly for the second two weeks.

Interventions

Suvorexant (dual orexin receptor antagonist)

Veteran patients with Major Depressive Disorder and elevated risk of suicide will receive the FDA-approved drug Suvorexant (brand name: Belsomra), a dual orexin receptor antagonist, for four weeks. Participants will take 10mg of Surovexant nightly for the first two weeks and 20mg of Surovexant nightly for the second two weeks.

Primary outcome measure

  • Implicit Association Tests (IATs) [ Time Frame: Weeks 1, 3, and 5 ]

Central Contacts and Locations

Central contacts

Marianne Goodman, MD

718-584-9000Marianne.Goodman@va.gov

James Murrough, MD, PhD

212-585-4640James.Murrough@va.gov

Locations

James J. Peters Veterans Affairs Medical Center

Recruiting

The Bronx, New York, United States, 10468

More Information

Sponsor

Marianne Goodman

Last update posted

Sep 25, 2025

Last verified

Sep, 2025

Keywords

  • Suicide risk
  • Proof-of-concept clinical trial
  • Suvorexant
  • Orexin antagonist

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Marianne Goodman on 2025-09-25.