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

Launched by MARIANNE GOODMAN · Feb 25, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "Orexin Antagonism for Suicide Risk," is exploring a medication called suvorexant to see if it is safe and well-tolerated for veterans who have Major Depressive Disorder (MDD) and are at risk for suicide. The main goal is to determine if this medication can be a helpful option for those struggling with these serious issues. Participants in the study will take suvorexant daily for four weeks, starting with a lower dose for the first two weeks and then increasing it. They will make several visits to the medical center for check-ups and will also fill out questionnaires about their feelings and experiences during the trial.

To be eligible for this study, participants need to be veterans aged 18 to 70 who have been diagnosed with MDD and have a history of suicidal thoughts or attempts. However, there are some important criteria that could exclude someone from participating, such as having certain medical conditions, being pregnant, or having a severe mental health disorder. This study is not currently recruiting participants, but it aims to gather valuable information that could lead to new treatment options for individuals at risk of suicide.

Gender

ALL

Eligibility criteria

• Inclusion 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)
• Exclusion Criteria:
• • 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.