NCT06854224RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 25 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 25 Feb 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Marianne Goodman
- Diseases
- Depression
- NCT number
- NCT06854224
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 1 Sept 2025 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of strong CYP3A live enzymes or moderate CYP3A inhibitors or strong CYP3A inducers
Other illness
- Clinically significant medical or neurological condition
- Active substance use disorder in the last six months, disorder, or current or past psychotic disorder, bipolar disorder, or obsessive-compulsive disorder
- 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.
Other
- Current use of digoxin
- Currently pregnant, not using contraception, nursing, or trying to become pregnant
- Severe traumatic brain injury
- Imminent suicidal or homicidal risk
Who the study is looking for
- 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)
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| James J. Peters Veterans Affairs Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.