[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651953":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":46,"collaborators":49,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":20,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":78,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Emory University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intravenous Ketamine During sEEG Monitoring","EXPERIMENTAL","Adults undergoing clinically indicated sEEG monitoring for epilepsy who have at least mild depressive symptoms will receive a single intravenous ketamine infusion (0.5 mg\u002Fkg over 40 minutes). Neural, behavioral, and symptom assessments will be performed before and approximately 24 hours after infusion to evaluate electrophysiologic correlates of antidepressant response.",[13],"Drug: Ketamine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Ketamine","Participants will receive one subanesthetic intravenous ketamine infusion administered at a dose of 0.5 mg\u002Fkg over 40 minutes during admission to the Epilepsy Monitoring Unit. The infusion will be supervised by a psychiatrist experienced in ketamine administration and conducted under continuous clinical monitoring. Intracranial sEEG recordings, behavioral assessments, and symptom measures collected before and approximately 24 hours after infusion will be used to evaluate electrophysiologic biomarkers associated with antidepressant response",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Carl Hacker, MD, PhD","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","404-778-5770","carl.hacker@emory.edu",[31],{"facility":5,"status":20,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Atlanta","Georgia","30322","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-84.38798,33.749,{"lat":41,"lon":40},[44,45],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":24,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Carl Hacker","Assistant Professor",[50],{"name":51,"class":52},"National Institutes of Health (NIH)","NIH","100651953","phase-2-electrophysiologic-mechanisms-of-ketamine-antidepressant-response-100651953",false,"NCT07768618","Electrophysiologic Mechanisms of Ketamine Antidepressant Response","Electrophysiologic Dynamics of Depression and Antidepressant Response in Epilepsy","Ketamine-sEEG","Inclusion Criteria:\n\n* Admitted to the Emory EMU for clinically indicated sEEG monitoring for epilepsy.\n* At least mild depressive symptoms at baseline, defined as MADRS ≥7 or BDI-II ≥14.\n* Electrode coverage that includes midline regions sufficient for enrollment and analyses.\n* Ability to provide informed consent and to complete bedside tasks\u002Fquestionnaires in English.\n* Expected to remain under inpatient monitoring through the planned \\~24-hour post-infusion follow-up unless clinical needs dictate otherwise.\n\nExclusion Criteria:\n\n* Documented IQ \\\u003C70, intellectual disability, severe cognitive impairment, delirium, severe aphasia, or other condition that prevents valid consent or task participation.\n* Current or past schizophrenia-spectrum disorder or other psychotic disorder.\n* Current manic\u002Fhypomanic episode or bipolar-spectrum illness judged by study psychiatrist\u002Finvestigator to increase risk or confound interpretation.\n* Active alcohol or substance abuse\u002Fdependence within the past 3 months.\n* Imminent suicide risk or active suicidal intent requiring urgent intervention as determined by clinical assessment. Passive ideation without imminent intent may be considered on a case-by-case basis with psychiatric approval and enhanced monitoring.\n* Contraindication to subanesthetic ketamine, including uncontrolled hypertension, unstable cardiovascular disease, aneurysm\u002Fvascular malformation or similar condition conferring unacceptable risk, pregnancy, breastfeeding, or other clinically significant medical instability.\n* Clinical team determination that ketamine administration or study timing would interfere with epilepsy care or perioperative management.\n* Sedative or other medication exposure at a level that, in the judgment of the clinical team, precludes safe ketamine administration or reliable behavioral assessment (participant may be deferred rather than permanently excluded if the issue resolves).","ALL","18 Years",{"count":64,"type":65},37,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","This study aims to identify electrophysiologic biomarkers associated with antidepressant response to ketamine in adults with epilepsy undergoing clinically indicated stereo-electroencephalography (sEEG) monitoring who have at least mild depressive symptoms.\n\nParticipants will receive a single subanesthetic intravenous ketamine infusion (0.5 mg\u002Fkg over 40 minutes) during their Epilepsy Monitoring Unit admission. Intracranial neural recordings and behavioral assessments will be collected before and approximately 24 hours after infusion to examine changes in neural circuits associated with rumination and anhedonia.",[71,72],"Epilepsy","Depressive Symptoms",[74,71,17,75,76,77],"Depression","Stereo-electroencephalography","Antidepressant Response","Electrophysiologic Biomarker","NOT_YET_RECRUITING","2026-08-12",{"date":81,"type":82},"2026-08-17","ACTUAL",{"date":84,"type":65},"2026-12",{"date":86,"type":65},"2031-12",{"name":5,"class":6},1]