[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bipolar-disorder-nos\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bipolar-disorder-nos":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,81],{"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":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100054230","phase-4-exercise-and-olanzapine-samidorphan-100054230",false,"NCT06740890","Exercise and Olanzapine-samidorphan","A Proof of Concept Study of Time Limited Exercise Plus Olanzapine-samidorphan for the Prevention of Early Weight Gain","Inclusion Criteria:\n\n1. Age between 18-65, inclusive at Visit 1.\n2. DSM-V diagnosis of schizophrenia or schizoaffective or Bipolar I\u002FII\u002FNOS disorder at Visit 1.\n3. Body Mass Index (BMI) of 18.0-40.0 kg\u002Fm2, inclusive, at Visits 1 and 2.\n4. Willing to provide informed consent at Visit 1.\n5. Medically and psychiatrically stable for study participation at Visit 1.\n6. Responsive to an antipsychotic treatment (other than clozapine) in the past 5 years prior to Visit 1.\n7. Can benefit from participation in this study and has a reason to participate, such as inadequate efficacy on current treatment, side effects on current treatment, desire to start olanzapine-samidorphan or try structured exercise program (assessed at Visit 1).\n8. Maintained a stable body weight (change \\\u003C 5%) for at least 3 months prior to Visit 1.\n9. Willing to use qualified methods of contraception (listed in section 5.3) for the study duration (for women of childbearing potential only) (assessed at Visit 1 and Visit 2).\n\nExclusion Criteria:\n\n1. Positive drug screen for opioids, phencyclidine, amphetamine\u002F methamphetamine, or cocaine at Visit 1 or Visit 2.\n2. Diagnosis of moderate or severe substance use disorder, anorexia nervosa, bulimia, binge eating disorder or any other clinically significant eating disorder at Visit 1.\n3. EKG abnormality that is clinically significant including a QT interval \\> 450 msec for men and \\> 470 msec for women, as corrected by the Fridericia formula (QTcF) at Visit 1.\n4. Use of olanzapine+samidorphan for any reason in the last six months prior to Visit 1, any history of poor or inadequate response to treatment with olanzapine or no justifiable reason to expect improvement on olanzapine as assessed at Visit 1.\n5. Taken opioid agonists (e.g., codeine, oxycodone, tramadol, or morphine) within the 14 days prior to Visit 1 and\u002For anticipates a need to take opioid medication during the study period (e.g., planned surgery), or has taken opioid antagonists including naltrexone (any formulations) or naloxone within 60 days prior to Visit 1.\n6. Pregnant or breast feeding women. Women of child-bearing potential must have a negative serum beta-hCG pregnancy test at Visit 1 and a negative urine pregnancy test at Visit 2.\n7. Any clinically significant or unstable medical illness, condition, or disorder that is anticipated to potentially compromise subject safety on study medication or exercise, or adversely affect the evaluation of efficacy, including (but not necessarily limited to) the following (as assessed at Visit 1):\n\n   1. Clinically significant hypotension or hypertension not stabilized on medical therapy.\n   2. Unstable thyroid dysfunction in the past 6 months (e.g., hypothyroidism, hyperthyroidism, or thyroiditis that was untreated, or discovered and treatment was initiated within the 6 months prior to screening).\n   3. Personal or family history of neuroleptic malignant syndrome, has a history of clinically significant extrapyramidal symptoms when taking olanzapine, or has had clinically significant tardive dyskinesia.\n   4. Neurological conditions include the following:\n\n      * History of seizure disorder or a condition associated with seizures (except history of febrile seizures).\n      * History of brain tumor, subdural hematoma, stroke or any other clinically significant neurological condition within the 12 months prior to Visit 1.\n      * Head trauma with loss of consciousness within the 12 months prior to Visit 1.\n      * Active, acute or chronic CNS infection.\n   5. Cardiac condition that might confound study results, pose additional risk when administering the study drug or exercise regimen to the subject, or preclude successful completion of the study. Conditions include the following:\n\n      * Clinically significant cardiac arrhythmia, cardiomyopathy, a cardiac conduction defect, or a history of myocardial infarction or unstable angina within 6 months prior to Visit 1.\n8. Currently taking any contraindicated medications as per the approved labeling for Olz-Sam (see section 6.5 for details) at Visit 1 and Visit 2.\n9. Subjects with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 3 months prior to Visit 1 or current at Visit 2\n10. Inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss at Visit 1.\n11. Joined a weight management program or had significant changes in diet or exercise regimen within 6 weeks prior to Visit 1 or plans to join a weight management program during the study as assessed at Visit 1.\n12. History of diabetes (assessed at Visit 1).\n13. Laboratory abnormality that would compromise the well-being of the subject, or any of the following specific laboratory results at Visit 1:\n\n    1. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value \\> 2 times the upper limit of the laboratory normal reference range\n    2. Absolute neutrophil count (ANC) \\\u003C1.5 x 10\\^3 μL\n    3. Platelet count \\\u003C 75 x 10\\^3 uL\n    4. Serum creatinine \\> 1.5 mg\u002FdL\n    5. Dyslipidemia, defined for this study as total fasting cholesterol \\> 280 mg\u002FdL or fasting triglycerides \\> 500 mg\u002FdL\n    6. Hemoglobin A1c (HbA1c) \\> 6.0%\n    7. Fasting plasma glucose \\> 126 mg\u002FdL (7.0 mmol\u002FL)\n14. Is not fit for the trial in the opinion of the investigator at Visit 1 and Visit 2.","ALL","18 Years","65 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This is a single site trial in 30 patients with schizophrenia, schizoaffective, or bipolar I\u002FII\u002FNOS disorder in which all participants will receive eight weeks of olanzapine and samidorphan (Olz\u002FSam) plus four weeks of aerobic exercise.",[27,28,29,30],"Schizophenia Disorder","Schizoaffective Disorder","Bipolar Disorder I or II","Bipolar Disorder NOS",[32,33,34],"Exercise","Antipsychotic induced weight gain","olanzapine-samidorphan","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2025-06-26",{"date":43,"type":21},"2027-04",{"name":45,"class":46},"New York State Psychiatric Institute","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100586865","child-bipolar-network-ketogenic-diet-approach-to-bipolar-disorder-in-adolescents-100586865","NCT06920940","Child Bipolar Network Ketogenic Diet Approach to Bipolar Disorder in Adolescents","CBN Keto","Inclusion Criteria:\n\n* Youth must be ages 12 to 21 years old and speak English\n* Youth must be appropriate for outpatient treatment (i.e., not a danger to self or others; not acutely psychotic, suicidal or manic; not in need of partial or full hospitalization)\n* Youth must have a current BSD (bipolar I, II per DSM-5 criteria (Association, 2013) or other specified BSD by the University of Pittsburgh diagnostic criteria (Birmaher et al., 2006). The Pittsburgh other specified BSD criteria require recurrent and distinct 1-3 day periods (minimum 4 hours\u002Fday) in which there has been abnormally elevated, expansive, or irritable mood plus two (three, if irritable mood only) symptoms of mania that caused a change in functioning and totaled at least 4 days in the child's lifetime\n* Active symptoms: In the 2 weeks prior to study intake, participants must have had weekly depression Psychiatric Status Ratings (PSRs) of 3 (moderate) or higher (using the 1-6 depression severity scales from the Adolescent Longitudinal Follow-up Evaluation, or A-LIFE); or an interview-based Children's Depression Rating Scale, Revised (CDRS-R) score covering the prior 2 weeks of \\> 20. Youth may also enter with mixed symptoms (e.g., simultaneous elevations of \\> 3 on the PSR depression and hypomania scales, with Young Mania Rating Scale scores of 12 or higher), without meeting criteria for a full manic episode in the past month.\n* Participants must continue to meet the study's active symptom criteria when beginning the phase II keto \"ramp-up\" phase: a depression PSR rating of 3 or higher over the prior 2 weeks, and a CDRS-R score covering the prior 2 weeks of \\> 20.\n* Youth\u002Fparents must be willing to participate in evaluation and medication management sessions with a study psychiatrist and the study dietitian for assessment of the diet and side effects.\n* Youth under 18 years old must have at least one English-speaking parent or other caregiving family member consenting to participate in the study and available for consultation if needed\n* Youth and (for minors) all parents\u002Flegal guardians with health care decision making rights must express willingness to have the youth be in the study and try the keto therapy, assuming that the youth is eligible. The team must ascertain that the participating minor's youth\u002Fcaregiver is likely to make a strong effort to adhere to the study's protocol.\n\nExclusion Criteria:\n\nThe youth must not have any of the following needs or conditions for which the keto diet may be contraindicated:\n\n* pregnancy or breastfeeding\n* underweight (BMI below 18.5) or wasting syndrome (e.g., anorexia cachexia)\n* current or history of anorexia nervosa\n* current disordered eating (bulimia or binge eating disorder)\n* autism spectrum disorder diagnosis level 2 or greater (more than mild)\n* cardiac issues, including history of arrhythmia, or cardiovascular or cerebrovascular disease\n* type I and type II diabetes\n* history of seizures\u002Fepilepsy\n* history of stroke or cancer\n* unstable respiratory condition\n* severe gastroesophageal reflux (GERD; painful\u002Fimpairing despite prescription medication)\n* substance use disorder (with an exception for mild cannabis or nicotine use disorders)\n* history of kidney stones\u002Fdisease\n* diseases involving the pancreas, liver, gallbladder or thyroid, including Von Gierke's glycogen storage disease\n* Condition with high cholesterol of triglycerides will prompt physician review of eligibility (LDL\\>190 or triglycerides\\>500)\n* genetic metabolic disorders: either porphyria (impacting the body's ability to make hemoglobin) or fatty acid oxidation disorder (FAOD)\n* rare conditions of defective ketone production or breakdown (carnitine deficiency, carnitine palmitoyl-transferase deficiency, carnitine-acylcarnitine translocase deficiency, mitochondrial fatty acid β-oxidation disorders, Succinyl-CoA:3-ketoacid CoA transferase deficiency (SCOT), or pyruvate carboxylase deficiency)\n* youth must not be taking SGLT-2 inhibitors (e.g., canagliflozin), insulin, or sulfonylureas (to avoid hypogycemia), or Antihypertensive medication (e.g., lisinopril\u002FACE Angiotensin inhibitors ending in \"pril\", ARB Angiotensin II receptor blockers, spironolactone\u002FAldactone, Thiazide-type diuretics)","12 Years","21 Years",{"count":58,"type":21},80,[60],"NA","The present study is an open trial of ketogenic diets for adolescents and young adults (ages 12-21 yrs) in the depressive or mixed phases of bipolar disorder (BD). The investigators aim to determine whether combining standard of care pharmacological treatment for bipolar spectrum disorders with a 16-week ketogenic diet is well-tolerated and associated with improvements in depression, inflammatory and metabolic indicators, and executive functioning over the study period.\n\nThe experimental treatment in this study is a 16-week full ketogenic diet. Four study sites (UCLA, U Cincinnati, U Colorado and U Pittsburgh) will recruit 80 total youth (20 each) from bipolar specialty clinics. All youth eligible for the ketogenic therapy will be provided with the ketogenic diet and standard of care pharmacological treatment. During the diet therapy youth will be seen by a study child\u002Fadolescent psychiatrist at least once a month (and more frequently when needed), with the psychiatrist recommending and providing side effects monitoring and pharmacotherapy as clinically indicated.\n\nThe youth and caregivers will also meet with an expert dietitian who will coach all youth on maintaining the ketogenic diet (low carbs, high fats, medium protein) and making sure the child is tolerating the diet and getting enough liquid and nutrients, following the practice guidelines of the International Ketogenic Diet Study Group for treating youth. All youth and involved caregivers will also be provided will at least one motivational enhancement session to support them in goal setting and completion of the study elements.\n\nThroughout the study the investigators will assess metabolic (e.g., blood ketones, HOMA-IR) and inflammatory indicators (e.g., C-reactive protein), both for safety reasons and to assess correlates of symptomatic change. Independent evaluators will assess youth every month regarding their symptoms (depression, mania, anxiety, psychosis), psychosocial functioning, and quality of life.\n\nThe investigators anticipate that the pilot will transpire over 24 months and be an important step toward establishing feasibility and acceptability of ketogenic therapy for this population, not only in terms of diet administration and compliance but also for obtaining symptomatic, metabolic and inflammatory measurements.",[63,30,29,64,65],"Bipolar Disorder (BD)","Bipolar Spectrum Disorder","Adolescents",[67,68,69,70],"ketogenic","treatment","diet","keto","2026-04-17",{"date":73,"type":39},"2026-04-22",{"date":75,"type":39},"2025-03-19",{"date":77,"type":21},"2027-03-19",{"name":79,"class":46},"University of California, Los Angeles",4,{"id":82,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":25,"conditions":85,"keywords":86,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":91,"leadSponsor":92,"locationsCount":47},"100573024",{"count":20,"type":21},[24],[27,28,29,30],[32,33,34],"2025-07-08",{"date":89,"type":39},"2025-07-11",{"date":41,"type":39},{"date":43,"type":21},{"name":45,"class":46}]