[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616604":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":39,"locations":45,"responsibleParty":60,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":30,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":30,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":92,"whyStopped":30,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Soterix Medical","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Low level ketamine","EXPERIMENTAL","0.25 mg\u002Fkg ketamine infusion",[13],"Drug: Ketamine (0.25 mg\u002Fkg)",{"label":15,"type":10,"description":16,"interventionNames":17},"Medium level ketamine","0.5 mg\u002Fkg ketamine infusion",[18],"Drug: Ketamine (0.5 mg\u002Fkg)",{"label":20,"type":10,"description":21,"interventionNames":22},"High level ketamine","0.75 mg\u002Fkg ketamine infusion",[23],"Drug: Ketamine (0.75 mg\u002Fkg)",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Ketamine (0.25 mg\u002Fkg)","Low level ketamine infusion therapy.",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Ketamine (0.5 mg\u002Fkg)","Medium level ketamine infusion therapy.",[15],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Ketamine (0.75 mg\u002Fkg)","High level ketamine infusion therapy.",[20],[40],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},"Yishai Valter, MS","CONTACT","8889908327","trials@soterixmedical.com",[46],{"facility":47,"status":30,"city":48,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Columbia University Irving Medical Center","New York","10032","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-74.00597,40.71427,{"lat":56,"lon":55},[59],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},{"type":61,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[63],{"name":64,"class":65},"Columbia University","OTHER","100616604","phase-1-ketamine-biomarker-validation-100616604",false,"NCT07307768","Ketamine Biomarker Validation","EEG Biomarker Development for Ketamine Administration","Inclusion Criteria:\n\n* Physically healthy patients who meet DMS-5 criteria for a major depressive episode (MDE) in the context of MDD and who score at least 22 on the Montgomery-Åsberg Depression Rating Scale (MADRS)\n* If taking antidepressants, dose is stable for at least 6 weeks.\n\nExclusion Criteria:\n\n* Lifetime history of bipolar disorder, schizoaffective disorder, schizophrenia, or any other psychotic disorder, including MDD with psychotic features\n* A first-degree relative with bipolar disorder, schizoaffective disorder, or schizophrenia, with the potential participant younger than 33 years (i.e., still at age of risk for a psychotic disorder)\n* Receipt of electroconvulsive therapy within 3 months of enrolling in the study\n* History of IV drug use\n* Nonresponse or intolerance to ketamine administered either clinically or as part of a prior research study\n* Pregnancy, planning to conceive, or sexually active but not using adequate birth control.\n* Actively suicidal (CSSRS≥3)\n* No antipsychotics or medications (e.g. benzodiazepines, anti-epileptics) that are likely to interact with GABA or glutamate,","ALL","18 Years","59 Years",{"count":77,"type":78},20,"ESTIMATED","INTERVENTIONAL",[81],"PHASE1","We will be developing an EEG-based biomarker for the effects of ketamine infusion in patients with Depression. We will be analyzing the effects of ketamine infusion on Depression symptoms and EEG signals.",[84],"Treatment Resistant Depression (TRD)",[86,87,88,89,90,91],"Ketamine","EEG","Depression","MDD","unipolar Depression","Biomarker","NOT_YET_RECRUITING","2025-12-15",{"date":95,"type":96},"2025-12-29","ACTUAL",{"date":98,"type":78},"2025-12-20",{"date":100,"type":78},"2028-03-01",{"name":5,"class":6},1]