RecruitingPhase 2NCT06854224

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

Sponsor

Marianne Goodman

Enrollment

30 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder (MDD)Suicide Risk

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)

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a sleep medication called suvorexant (an orexin receptor blocker) can reduce suicidal thoughts and help veterans with major depression who have a history of suicide attempts sleep better. **You may be eligible if:** - You are a veteran between 18 and 70 years old - You have a primary diagnosis of major depressive disorder - You have a history of a suicide attempt and currently have suicidal thoughts **You may NOT be eligible if:** - You have a serious medical or neurological condition - You are currently taking certain medications that interact with the study drug (strong CYP3A inhibitors or inducers, or digoxin) - You are pregnant, trying to get pregnant, or not using contraception - You have had an active substance use disorder in the past 6 months, a psychotic disorder, or bipolar disorder - You have had a severe traumatic brain injury - You are at imminent risk of suicide or harming others Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSuvorexant (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.