Actively Recruiting
Orexin Antagonism to Target Mechanisms of Suicide Risk: A Proof-of-Concept Clinical Trial
Led by Marianne Goodman · Updated on 2025-09-25
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Marianne Goodman
Lead Sponsor
J
James J. Peters Veterans Affairs Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial investigates the safety, feasibility, and tolerability of the drug Suvorexant in adult veterans diagnosed with Major Depressive Disorder who have an increased risk of suicide. It aims to answer whether Suvorexant can be safely used and tolerated by participants in this group. The study is a phase 2 proof-of-concept clinical trial focusing on this important mental health concern. Participants will take Suvorexant, a dual orexin receptor antagonist, every night for four weeks. The dose is 10mg per night for the first two weeks, increasing to 20mg per night for the last two weeks. The treatment is given orally and is FDA-approved for other uses. Assessments happen in person at the start (week 1), after two weeks (week 3), and after four weeks (week 5) of treatment. During the study, participants will complete various self-report assessments remotely at weeks 2 and 4. In-person visits will include tests such as the Implicit Association Tests at weeks 1, 3, and 5, along with other behavioral and psychological scales to monitor aggression, impulsiveness, and suicidal ideation. Safety, tolerability, and adherence to treatment will be closely followed. The total study duration per participant is about five weeks.
CONDITIONS
Brief Title
Orexin Antagonism for Suicide Risk: A Proof-of-Concept Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veteran
- Between 18 and 70 years of age
- Primary diagnosis of Major Depressive Disorder confirmed by psychiatrist and MINI
- History of at least one suicide attempt and current suicidal ideation as indicated by a score of 2 or higher on the Columbia-Suicide Severity Rating Scale
You will not qualify if you...
- Clinically significant medical or neurological condition
- Current use of strong CYP3A liver enzyme modifiers or digoxin
- Currently pregnant, not using contraception, nursing, or trying to become pregnant
- Active substance use disorder within the past six months
- Current or past psychotic disorder, bipolar disorder, or obsessive-compulsive disorder
- Severe traumatic brain injury
- Imminent suicidal or homicidal risk
- Unstable medical conditions or contraindications to Suvorexant according to FDA label
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants take the drug Suvorexant nightly, starting with 10mg for the first two weeks and increasing to 20mg for the next two weeks.
Weekly visits for 4 weeks
Trial Site Locations
Total: 1 location
1
James J. Peters Veterans Affairs Medical Center
The Bronx, New York, United States, 10468
Actively Recruiting
Research Team
M
Marianne Goodman, MD
J
James Murrough, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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