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

Part of paid clinical trials in The Bronx, New York.

Sponsor
Marianne Goodman
Study ID
NCT06854224
Phase
PHASE2
Status
Recruiting
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Conditions

  • Major Depressive Disorder (MDD)
  • Suicide Risk

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Suvorexant (dual orexin receptor antagonist) — DRUG
    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.

Study Details

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)

Key Dates

Start date
Sep 1, 2025
Status verified
Sep 2025
Primary completion
Jul 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
James J. Peters Veterans Affairs Medical CenterThe BronxNew York10468-

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By research site
James J. Peters Veterans Affairs Medical Center· The Bronx, NY

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