[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Marianne Goodman\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"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":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"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)",[27,28],"Suicide Risk","Major Depressive Disorder (MDD)",[30,31,32,33],"Suicide risk","Proof-of-concept clinical trial","Suvorexant","Orexin antagonist","RECRUITING","2025-09-22",{"date":37,"type":38},"2025-09-25","ACTUAL",{"date":40,"type":38},"2025-09-01",{"date":42,"type":21},"2027-07-01",{"name":44,"class":45},"Marianne Goodman","OTHER",""]