[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636837":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":44,"centralContacts":49,"locations":54,"responsibleParty":70,"collaborators":73,"id":79,"slug":35,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":35,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":35,"enrollmentInfo":87,"targetDuration":35,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":100,"whyStopped":35,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,14,19,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral bipolar medication only","ACTIVE_COMPARATOR","Participants in this arm will receive oral medication treatment as usual for bipolar disorder. These medications may include second generation antipsychotic mood stabilizing medications aripiprazole, risperidone, quetiapine, and olanzapine.",[13],"Other: Standard of Care Oral antipsychotics",{"label":15,"type":10,"description":16,"interventionNames":17},"Long-acting injectable medication only","Participants in this arm will receive long-acting injectable medication as treatment for bipolar disorder. This medication may include aripiprazole monohydrate.",[18],"Other: Standard of care long acting injectable medication for bipolar disorder",{"label":20,"type":21,"description":22,"interventionNames":23},"Oral medication + ketogenic diet","EXPERIMENTAL","Participants in this arm will receive oral medication for bipolar disorder, plus foodstuffs necessary to support ketogenic diet. Oral medications may include second generation antipsychotic mood stabilizing medications aripiprazole, risperidone, quetiapine, and olanzapine.",[24,13],"Dietary Supplement: Ketogenic foodstuffs",{"label":26,"type":21,"description":27,"interventionNames":28},"Long-acting injectable medication + ketogenic diet","Participants in this arm will receive long-acting injectable medication for bipolar disorder, plus foodstuffs necessary to support ketogenic diet. The medication used may include aripiprazole monohydrate.",[24,18],[30,36,40],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DIETARY_SUPPLEMENT","Ketogenic foodstuffs","Weekly food box, selected from rotating menu of three options, as designed by study dietician to include ketogenic foodstuffs.",[26,20],null,{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Standard of Care Oral antipsychotics","Oral mood stabilizing antipsychotics for the treatment of bipolar disorder. These medications may include second generation antipsychotic mood stabilizing medications aripiprazole, risperidone, quetiapine, and olanzapine.",[9,20],{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"Standard of care long acting injectable medication for bipolar disorder","Long-acting injectable antipsychotic mood stabilizing medication for bipolar disorder. The medication used may include aripiprazole monohydrate.",[26,15],[45],{"name":46,"affiliation":47,"role":48},"Will Rutland, MD","UAB Heersink School of Medicine - Montgomery Psychiatry","PRINCIPAL_INVESTIGATOR",[50],{"name":46,"role":51,"phone":52,"phoneExt":35,"email":53},"CONTACT","334-747-7550","wrutland@uab.edu",[55],{"facility":56,"status":35,"city":57,"state":58,"zip":59,"country":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Baptist Medical Center South","Montgomery","Alabama","36116-2496","United States",{"type":62,"coordinates":63},"Point",[64,65],-86.29997,32.36681,{"lat":65,"lon":64},[68],{"name":46,"role":51,"phone":69,"phoneExt":35,"email":53},"3347477550",{"type":48,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Will Rutland","Regional Chair of Psychiatry - Montgomery Campus",[74,76],{"name":75,"class":6},"Baszucki Family Foundation",{"name":77,"class":78},"Baptist Health System Montgomery","UNKNOWN","100636837",false,"NCT07570875","Evaluating the Impact of Ketogenic Therapy on Symptom Severity and Metabolic Side Effect Profile Among Individuals Living With Bipolar Disorder in A Rural Southern Catchment Area","Evaluating the Impact of Ketogenic Therapy on Symptom Severity and Metabolic Side Effect Profile Among Individuals Living With Bipolar Disorder in A Rural Southern Catchment Area - A Four-Arm Pilot Study","Inclusion Criteria:\n\n* Age \\>18\n* Verified Bipolar Diagnosis per NETSCID\n\nExclusion Criteria:\n\n* Acute psychiatric instability (manic episode, active suicidality requiring hospitalization)\n* Anorexia\n* Pregnancy\n* Severe renal insufficiency\n* Hepatic insufficiency","ALL","18 Years",{"count":88,"type":89},100,"ESTIMATED","INTERVENTIONAL",[92],"NA","It is the purpose of this pilot study to evaluate a high-fat\u002Flow-carbohydrate \"ketogenic\" diet-based intervention as an adjunctive strategy for impacting symptoms of bipolar disorder. The study is designed to evaluate this impact in the rural southern catchment area around Montgomery, Alabama.\n\nWhile existing access and cost barriers can prevent effective treatment of bipolar disorder in the rural south, using food as medicine represents a possible alternative\u002Fadjunctive to traditional high-cost\u002Flow-access medications. Specifically, this study will evaluate the impact of combining a ketogenic diet with existing treatment options, under the conditions of the rural catchment area, to determine the impact and efficacy of this intervention at patient and systems levels.\n\nIf effective, the interventions examined in this pilot study may increase the efficacy, availability and access to care experienced by individuals living with bipolarity in the rural Deep South.",[95],"Bipolar Disorder",[97,98,99],"ketogenic","long-acting injectable","rural","NOT_YET_RECRUITING","2026-06-30",{"date":103,"type":104},"2026-07-02","ACTUAL",{"date":106,"type":89},"2026-08",{"date":108,"type":89},"2026-12",{"name":5,"class":6},1]