Suvorexant for Depression

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Marianne Goodman

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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)

Research Team

Eligibility Criteria

This trial is for veteran adults with Major Depressive Disorder and a high risk of suicide. Participants will take the drug Suvorexant daily for four weeks, with in-person visits at weeks 1, 3, and 5, plus remote self-reports at weeks 2 and 4.

Inclusion Criteria

Veteran

Lifetime suicide attempt history and suicidal ideation at baseline as determined by a score ≥2 on the Columbia-Suicide Severity Rating Scale (C-SSRS)

I have been diagnosed with Major Depressive Disorder by a psychiatrist.

Exclusion Criteria

Imminent suicidal or homicidal risk

I have a serious health or brain condition.

I am currently taking digoxin.

Treatment Details

Interventions

• Suvorexant (Orexin Antagonist)

Trial Overview The study tests the safety, feasibility, and tolerability of Suvorexant—a dual orexin receptor antagonist—in reducing suicidal thoughts among those with severe depression. The dosage increases from week two to four.

Participant Groups

Group I: Suvorexant group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Marianne Goodman

Lead Sponsor

Trials

1

Recruited

30+

VISN 2 Mental Illness Research & Education Clinical Center

Collaborator

Trials

1

Recruited

30+