[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581739":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":32,"responsibleParty":47,"collaborators":51,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":20,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Bronx Veterans Medical Research Foundation, Inc","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Suvorexant group","EXPERIMENTAL","Veteran patients with Major Depressive Disorder and elevated risk of suicide will receive the FDA-approved drug Suvorexant (brand name: Belsomra), a mixed Orexin antagonist, for four weeks. Participants will take 10mg of Surovexant nightly for the first two weeks and 20mg of Surovexant nightly for the second two weeks.",[13],"Drug: Suvorexant (dual orexin receptor antagonist)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Suvorexant (dual orexin receptor antagonist)","Veteran patients with Major Depressive Disorder and elevated risk of suicide will receive the FDA-approved drug Suvorexant (brand name: Belsomra), a dual orexin receptor antagonist, for four weeks. Participants will take 10mg of Surovexant nightly for the first two weeks and 20mg of Surovexant nightly for the second two weeks.",[9],null,[22,28],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":27},"Marianne Goodman, MD","CONTACT","718-584-9000","5188","Marianne.Goodman@va.gov",{"name":29,"role":24,"phone":30,"phoneExt":20,"email":31},"James Murrough, MD, PhD","212-585-4640","James.Murrough@va.gov",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":20},"James J. Peters Veterans Affairs Medical Center","RECRUITING","The Bronx","New York","10468","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-73.86641,40.84985,{"lat":45,"lon":44},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Marianne Goodman","Psychiatrist; VISN 2 MIRECC Director",[52],{"name":34,"class":53},"FED","100581739","phase-2-orexin-antagonism-for-suicide-risk-a-proof-of-concept-clinical-trial-100581739",false,"NCT06854224","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","Inclusion Criteria:\n\n* Veteran\n* At least 18 years of age (up to 70 years)\n* Primary diagnosis of Major Depressive Disorder as determined by the study psychiatrist and confirmed by the Mini-International Neuropsychiatric Interview (MINI)\n* Lifetime suicide attempt history and suicidal ideation at baseline as determined by a score ≥2 on the Columbia-Suicide Severity Rating Scale (C-SSRS)\n\nExclusion Criteria:\n\n* Clinically significant medical or neurological condition\n* Current use of strong CYP3A live enzymes or moderate CYP3A inhibitors or strong CYP3A inducers\n* Current use of digoxin\n* Currently pregnant, not using contraception, nursing, or trying to become pregnant\n* Active substance use disorder in the last six months, disorder, or current or past psychotic disorder, bipolar disorder, or obsessive-compulsive disorder\n* Severe traumatic brain injury\n* Imminent suicidal or homicidal risk\n* 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.","ALL","18 Years","70 Years",{"count":65,"type":66},30,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","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?\n\nParticipants will:\n\n* Take Surovexant every day for four weeks (10mg in the first two weeks and 20mg in the second two weeks)\n* 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.\n* Fill out self-report assessments (remotely) at week 2 (after one week of Suvorexant) and week 4 (after three weeks of Surovexant)",[72,73],"Suicide Risk","Major Depressive Disorder (MDD)",[75,76,77,78],"Suicide risk","Proof-of-concept clinical trial","Suvorexant","Orexin antagonist","2025-09-22",{"date":81,"type":82},"2025-09-25","ACTUAL",{"date":84,"type":82},"2025-09-01",{"date":86,"type":66},"2027-07-01",{"name":49,"class":6},1]