[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533133":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":41,"responsibleParty":59,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":24,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":24,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":44,"whyStopped":24,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Mclean Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketogenic diet arm","ACTIVE_COMPARATOR","Eligible participants assigned to the ketogenic diet arm will be asked to follow the ketogenic diet (KD) for 12 weeks in addition to any ongoing medications (e.g., mood stabilizers and\u002For second-generation antipsychotics). Participants will receive weekly and as needed diet counseling from a registered dietician. Participants will be asked to monitor and report their blood ketone levels each day via a finger-prick device provided by the study team. Participants have the ability to opt into an optional open label phase where they can continue on the ketogenic diet with the daily finger pricks for another 12 weeks after the 12-week main study.",[13],"Other: Ketogenic diet",{"label":15,"type":10,"description":16,"interventionNames":17},"Dietary Guidelines for Americans arm","Eligible participants assigned to the Dietary Guidelines for Americans (DGA) arm will adhere to the Dietary Guidelines for Americans in addition to any ongoing medications (e.g., mood stabilizers and\u002For second-generation antipsychotics). Participants will receive weekly and as needed diet counseling from a registered dietician. Participants will be asked to monitor and report their blood ketone levels each day via a finger-prick device provided by the study team. Participants have the ability to opt into an optional open label phase where they can switch to the ketogenic diet with the daily finger pricks for 12 weeks after the 12-week main study.",[18],"Other: Dietary Guidelines for Americans",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Ketogenic diet","The ketogenic diet (KD) is a normo-caloric diet composed of high-fat, low carbohydrate, and adequate protein intake. The KD will consist of 3 meals a day plus snacks, targeting 75-80% fat, 13-18% protein, 7% carbohydrates.",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Dietary Guidelines for Americans","Dietary Guidelines for Americans diet is a normo-caloric diet consisting of 3 meals a day plus snacks, emphasizing nutrient dense foods to meet food group needs (85% of calories), and limits foods and beverages higher in added sugars and saturated fat (15% of calories).",[15],[30],{"name":31,"affiliation":5,"role":32},"Virginie-Anne Chouinard, MD","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Jacey Anderson, B.A.","CONTACT","617-855-3988","janderson75@mclean.harvard.edu",{"name":31,"role":36,"phone":24,"phoneExt":24,"email":40},"vchouinard@mclean.harvard.edu",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"McLean Hospital","RECRUITING","Belmont","Massachusetts","02478","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-71.17867,42.39593,{"lat":54,"lon":53},[57,58],{"name":35,"role":36,"phone":24,"phoneExt":24,"email":38},{"name":31,"role":32,"phone":24,"phoneExt":24,"email":24},{"type":32,"investigatorFullName":31,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Psychiatrist",[62],{"name":63,"class":6},"Baszucki Family Foundation","100533133","ketogenic-and-nutritional-interventions-for-first-episode-bipolar-disorder-100533133",false,"NCT06221852","Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder","A Randomized Controlled Clinical Trial of Ketogenic and Nutritional Interventions for Brain Energy Metabolism and Psychiatric Symptoms in First Episode Bipolar Disorder.","Inclusion Criteria:\n\n* Between the ages of 18 and 45.\n* Ability to adhere to study diets.\n* Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnosis of bipolar I disorder or schizoaffective disorder with onset of illness in the last 7 years.\n* Must have a stable psychiatric disorder with no change in psychiatric medications within the past 2 weeks of screening\n* Must not be expected to require addition of any new psychiatric medications during the 12-week duration of the study.\n\nExclusion Criteria:\n\n* Unable to sign informed consent\n* Contraindication to magnetic resonance (MR) scan (including claustrophobia)\n* Unstable medical illness (including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease)\n* Current DSM-5 substance use disorder\n* Currently pregnant, nursing, or of childbearing potential and not using a medically accepted means of contraception\n* Have a body weight of over 350 lbs or a body mass index (BMI) \\\u003C20\n* Score above 15 on the Young Mania Rating Scale (YMRS)\n* History of significant head injury\n* Current cancer diagnosis\n* Current diagnosis of type 1 or type 2 Diabetes Mellitus\n* History of gastric bypass surgery or any weight loss surgery\n* Concomitant treatment with Propofol\n* Familial hypercholesterolemia","ALL","18 Years","45 Years",{"count":75,"type":76},50,"ESTIMATED","INTERVENTIONAL",[79],"NA","This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder.",[82,83,84],"Bipolar I Disorder","Psychosis","Schizoaffective Disorder",[86,87,88,89,90,84,91,92,93,94],"First episode psychosis","Ketogenic Diet","Keto","Brain energy metabolism","Insulin resistance","Bipolar Disorder","Magnetic resonance spectroscopy (MRS)","Redox","Creatine kinase","2025-11-04",{"date":97,"type":98},"2025-11-05","ACTUAL",{"date":100,"type":98},"2024-03-12",{"date":102,"type":76},"2027-12-30",{"name":5,"class":6},1]