NCT06854224 Orexin Antagonism for Suicide Risk: A Proof-of-Concept Clinical Trial
| NCT ID | NCT06854224 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Marianne Goodman |
| Condition | Suicide Risk |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-09-01 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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)
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06854224 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Suicide Risk. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06854224 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06854224 currently recruiting?
Yes, NCT06854224 is actively recruiting participants. Contact the research team at Marianne.Goodman@va.gov for enrollment information.
Where is the NCT06854224 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT06854224 clinical trial?
NCT06854224 is sponsored by Marianne Goodman. The trial plans to enroll 30 participants.