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New treatment option for Suicide Risk
Official title Orexin Antagonism for Suicide Risk: A Proof-of-Concept Clinical Trial
ClinicalTrials.gov ID: NCT06854224
What this study is testing
What is Suvorexant (dual orexin receptor antagonist)?
Suvorexant (dual orexin receptor antagonist) is an investigational medicine, being studied as a potential treatment for suicide risk.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Lifetime suicide attempt history and suicidal ideation at baseline as determined by a score ≥2 on the Columbia-Suicide Severity Rating Scale (C-SSRS)
You likely can't join if
- 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...
- Severe traumatic brain injury
See the full eligibility 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)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.