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Recruiting NCT06854224

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

Phase II Interventional Suicide Risk Major Depressive Disorder (MDD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Suvorexant (dual orexin receptor antagonist).
Who it may be relevant to
Registry conditions: Suicide Risk, Major Depressive Disorder (MDD). Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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)

Interventions

  • Drug 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 measures

  • Implicit Association Tests (IATs) [Time frame: Weeks 1, 3, and 5]
Secondary outcome measures (8)
  • Buss-Perry Aggression Questionnaire [Time frame: Weeks 1, 2, 3, 4, and 5]
  • Overt Aggression Scale Modified [Time frame: Weeks 1, 2, 3, 4, and 5]
  • Point Subtraction Aggression Paradigm [Time frame: Weeks 1, 3, and 5]
  • Barratt Impulsiveness Scale [Time frame: Weeks 1, 2, 3, 4, and 5]
  • Beck Scale for Suicidal Ideation [Time frame: Weeks 1, 2, 3, 4, and 5]
  • Columbia Suicide Severity Rating Scale [Time frame: Weeks 1, 2, 3, 4, and 5]
  • Gradual-Onset Continuous Performance Task [Time frame: Weeks 1, 3, 5]
  • Emotional Gradual Onset Continuous Performance Task [Time frame: Weeks 1, 3, and 5]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • James J. Peters Veterans Affairs Medical Center — The Bronx

Identifiers

NCT: NCT06854224 · 1851192

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗