[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bipolar-disorder-i-or-ii\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bipolar-disorder-i-or-ii":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,48,80,116,148,176,188,218],{"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":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":47},"100638156","focus-bipolar-families-opening-conversations-for-understanding-signs-100638156","NCT07622927","FOCUS Bipolar: Families Opening Conversations for Understanding Signs","A Data-Driven Approach to Early Mental Health Screening in Offspring of Parents With Bipolar Disorder","FOCUS Bipolar","Inclusion Criteria for Group A - Parent with Bipolar Disorder:\n\n1. Age: 18 years or older.\n2. Confirmation of a lifetime Bipolar I or II diagnosis\n3. Parent status: Has at least one biological child aged 7-21 years.\n4. Capacity and willingness to consent: Able and willing to provide informed consent.\n5. Study participation: Able to comply with study procedures (e.g., co-design sessions, interviews, assessments).\n6. Language: Able to read, speak, and understand English.\n\nInclusion Criteria for Group B - Adult Caregiver:\n\n1. Age: 18 years or older.\n2. Caregiver status: The adult primarily responsible for the daily care and\u002For medical decisions for ≥ 6 months for a child aged 7-21 years whose biological parent has a lifetime, clinician-confirmed diagnosis of Bipolar I or II disorder.\n3. Capacity and willingness to consent: Able and willing to provide informed consent.\n4. Study participation: Able to comply with study procedures (e.g., co-design sessions, interviews, assessments).\n5. Language: Able to read, speak, and understand English.\n\nInclusion Criteria for Group C - At-Risk Youth:\n\n1. Age:\n\n   1. Phase 1 (co-design) and Phase 2A (alpha testing): 13-18 years\n   2. Phase 2B (beta testing): 13-18 years\n   3. Phase 3 (screening): 7-21 years\n2. Diagnosis status: Must not have a current diagnosis of Bipolar I or II disorder.\n3. Parental diagnosis: Has at least 1 biological parent with a lifetime, clinician-confirmed Bipolar I or II diagnosis (as defined in Groups A and B).\n4. Consent\u002FAssent:\n\n   1. For youth aged 18-21: Able and willing to provide informed consent (verbal)\n   2. For youth aged 7-21: Parent\u002Fguardian\u002FLAR able and willing to provide informed consent (verbal) and youth able to provide assent (verbal)\n5. Participant ability: Able and willing to participate in study activities (e.g., co-design discussions, questionnaires, or screening assessments.\n6. Language: English sufficient to comprehend study procedures and materials.\n\nCriteria for Exclusion of Participants\n\nA potential participant will NOT be eligible for participation in this study if any of the following criteria are met:\n\n1. Unable to provide informed consent due to cognitive impairment or language barriers\n2. Experiencing acute psychiatric instability at enrollment (e.g., acute psychosis or acute suicidality without stabilization)\n3. Has a medical or psychiatric condition that, in the judgment of the Principal Investigator or study clinician, would place undue risk on the individual or interfere with standard clinical care",true,"7 Years",{"count":59,"type":21},200,"OBSERVATIONAL","Bipolar disorder often runs in families, but early symptoms in youth can go unrecognized for years. This project evaluates a structured, family-centered approach to informed screening for youth ages 7-21 who have a biological parent with bipolar disorder.\n\nThe main questions addressed by this project are:\n\nWhether a co-designed video decision aid improves caregiver understanding of bipolar disorder genetic risk and supports informed decisions about youth screening.\n\nWhether remote mental health screening tools are feasible and acceptable for youth with familial risk for bipolar disorder.\n\nWhether screening results can be used to identify early risk patterns and inform tailored follow-up recommendations.\n\nParticipants may be involved in one or more study activities, including co-design of educational decision-aid content, feedback on decision-aid prototypes, beta testing of the decision aid, and remote youth mental health screening. The study does not assign treatment and does not change existing clinical care or clinic routines.",[63,29,64,65],"Bipolar Disorder (BD)","Bipolar Disorder Family Members","Screening Tool",[67,68,69,70],"bipolar disorder","bipolar I","bipolar II","bipolar disorder screening","2026-05-27",{"date":73,"type":39},"2026-06-03",{"date":75,"type":39},"2026-03-11",{"date":77,"type":21},"2027-07-31",{"name":79,"class":46},"University of Texas Southwestern Medical Center",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":93,"conditions":94,"keywords":100,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":4},"100636708","phase-2-ketamine-with-dialectical-behavioural-therapy-dbt-for-suicidality-in-individuals-with-treatment-resistant-depression-and-borderline-personality-disorder-ket-dbt-100636708","NCT07569198","Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder (KET-DBT)","Combining Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder: A Phase II Randomized, Midazolam-Controlled Clinical Trial (KET-DBT)","KET-DBT","Inclusion Criteria:\n\n1. Adults between the age of 18 to 70, inclusive;\n2. Meets criteria for BPD, as determined by clinical assessment by a psychiatrist or psychologist and confirmed by the International Personality Disorder Examination (IPDE);\n3. Meets DSM-5 criteria for MDD or BD (I or II), currently experiencing a MDE without psychotic features, as diagnosed by a study psychiatrist or psychologist. Diagnosis will be confirmed using the Mini- International Neuropsychiatric Interview (MINI);\n4. Current MDE must be moderate to severe, as determined by the MADRS score \\>20 with an inadequate response to two or more guideline-concordant treatment trials as defined by the Antidepressant Treatment History Form-Short Form (ATHF- SF);\n5. No changes in pharmacotherapy for MDD\u002FBD in the last month or changes in psychotherapy in the past month;\n6. Baseline SI as shown by two consecutive MSSI scores \\> 10 two weeks apart.\n\nExclusion Criteria:\n\n1. Past or current history of a psychotic disorder as determined by clinical assessment and MINI;\n2. Current or recent (within the past 3 months) manic or hypomanic episode as determined by clinical assessment via YMRS (score \\> 12) and the MINI;\n3. Meeting criteria for Moderate to Severe Alcohol or substance use disorders currently or within the past 3 months;\n4. Lifetime history of ketamine use disorder or illicit ketamine use.\n5. Acute suicide risk requiring involuntary inpatient treatment under the Mental Health Act (MHA).\n6. Presence of a relative or absolute contraindication to ketamine or midazolam, including a drug allergy, lifetime history of stroke, uncontrolled hypertension (Systolic BP \\> 160 or Diastolic BP \\> 100), low or labile blood pressure (Systolic BP \\\u003C 100 or Diastolic BP \\\u003C 60), recent (within the past 6 months) myocardial infarction, severe coronary artery disease (ascertained through participant's medical history), or moderate to severe renal (GFR scores ≤ 44) or hepatic impairment (A Child-Pugh score of ≥ 7);\n7. Currently pregnant or breastfeeding or planning on getting pregnant within the first two months of the trial or planning on getting someone else pregnant within the first two months of trial. Participants who are sexually active must agree to use a highly effective contraceptive method (please see exhaustive list in Section 3.6.1);\n8. Current use of prohibited concomitant medications, including other forms of ketamine or esketamine, high dose daily benzodiazepines (greater than 4 mg lorazepam equivalent daily) or monoamine oxidase inhibitors;\n9. Currently engaged (or completed within the past year) in DBT treatment. NOTE: Individuals who have received only DBT skills training in the past year will be considered eligible to participate;\n10. Those engaged in other forms of psychotherapy must be willing to discontinue for the duration of the 6-month DBT intervention (standard for DBT). There should be no changes in psychotherapy 30 days prior to baseline (i.e., Screening Visit 2).","70 Years",{"count":90,"type":21},120,[92],"PHASE2","The goal of this clinical trial is to learn if intravenous (IV) ketamine with Dialectical Behavioural Therapy (DBT) reduces suicidal ideation in individuals with suicidality who have been diagnosed with Borderline Personality Disorder and either Major Depressive Disorder or Bipolar Disorder. The main question it aims to answer is:\n\nDoes IV ketamine and DBT produce more rapid and robust improvements in suicidal ideation (SI) severity between baseline and Day 35 compared to IV midazolam and DBT, as measured by changes in the Modified Scale for Suicidal Ideation (MSSI) scores ?\n\nResearchers will compare six IV ketamine infusions and DBT to an active placebo (a look-alike substance that mimics some of ketamine's effects and not others) and DBT to see if IV ketamine with DBT is more effective at reducing SI severity.\n\nParticipants will:\n\n* Complete six infusions of either IV ketamine or IV midazolam\n* Take part in 6 months of DBT (includes both weekly one-on-one sessions, and group sessions, starting week 5 of the trial)\n* Visit the hospital for scheduled in-person visits\n* Join a call or videocall for scheduled remote visits\n* Complete a variety of different mood, cognitive and behavioral assessments",[95,96,97,98,63,29,99],"Borderline Personality Disorder (BPD)","Treatment-Resistant Major Depressive Disorder","Treatment-resistant Bipolar Depression","Major Depressive Disorder (MDD)","Suicidal Ideation",[101,102,103,104,63,98,105],"Dialectical Behavioural Therapy (DBT)","ketamine","Borderline Personality Disorder","Treatment-Resistant Depression","Suicidality","NOT_YET_RECRUITING","2026-04-28",{"date":109,"type":39},"2026-05-06",{"date":111,"type":21},"2026-06-01",{"date":113,"type":21},"2029-08",{"name":115,"class":46},"Joshua Rosenblat",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":147},"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":126,"type":21},80,[128],"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.",[63,30,29,131,132],"Bipolar Spectrum Disorder","Adolescents",[134,135,136,137],"ketogenic","treatment","diet","keto","2026-04-17",{"date":140,"type":39},"2026-04-22",{"date":142,"type":39},"2025-03-19",{"date":144,"type":21},"2027-03-19",{"name":146,"class":46},"University of California, Los Angeles",4,{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":56,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":47},"100609998","decoding-emotional-dynamics-in-bipolar-disorder-100609998","NCT07221864","Decoding Emotional Dynamics in Bipolar Disorder","Decoding Emotional Dynamics Driving Mood Instability in Bipolar Disorder","Inclusion Criteria\n\n1. Age 18 to 65 years\n2. Male or female\n3. BMI between 18.5 and 38.0 kg\u002Fm2 at Screening\n4. Capable of understanding and complying with study requirements\n5. Fluent in English\n6. Able to provide informed consent\n\n   BD Group:\n7. Meet the DSM-5 diagnostic criteria for BD-I or BD-II who are currently depressed or mixed state defined by the Mini-International Neuropsychiatric Interview (MINI)\n8. Moderate or greater depressive symptom severity (MADRS ≥ 15 or PHQ-9 ≥ 10)\n\n   HC Group:\n9. No current or past psychiatric disorder (verified by MINI)\n\nExclusion Criteria\n\n1. No telephone or easy access to a telephone\n2. Significant medical problems as identified by the medical screening questionnaire: e.g. a history of unstable liver or renal insufficiency; glaucoma; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments\n3. A positive test for drugs of abuse, including alcohol (breath test), cocaine, opiates, amphetamines, methamphetamines, phencyclidine, benzodiazepines, barbiturates, methadone, and oxycodone\n4. Drug or alcohol intoxication (based on positive UTOX or breathalyzer test at screening or study session) or reported alcohol\u002Fdrug withdrawal, last cannabis use must be \\>48 hours prior to study session.\n5. Current DSM-5 diagnosis of a psychosis spectrum disorder or moderate to severe substance use disorder\n6. Moderate to severe traumatic brain injury or other neurocognitive disorder with evidence of neurological deficits, neurological disorders, or severe or unstable medical conditions that might be compromised by participation in the study (to be determined by primary care provider)\n7. Current significant suicidal ideation or suicide attempt within the past 3 months.\n8. Change in the dose or prescription of a medication within the 6 weeks before enrolling in the study that could affect brain functioning, e.g., anxiolytics, antipsychotics, antidepressants, or mood stabilizers\n9. Taking drugs that affect the fMRI hemodynamic response (e.g., methylphenidate, acetazolamide, excessive caffeine intake \\> 1000 mg\u002Fday)\n10. MRI contraindications as documented on the MR Environment Screening\n11. Unwillingness or inability to complete any of the major aspects of the study protocol, including magnetic resonance imaging (i.e., due to claustrophobia), or behavioral assessment. However, failing to complete some individual aspects of these assessment sessions will be acceptable (i.e., being unwilling to answer individual items on some questionnaires or being unwilling to complete a behavioral task)\n12. Non-correctable vision or hearing problems",{"count":156,"type":21},72,[128],"The goal of this neuroimaging study is to investigate how emotional states fluctuate in people with bipolar disorder (BD) compared to healthy controls, and to understand the neural mechanisms driving mood instability. The main questions it aims to answer are:\n\n* Can emotional states be decoded from fMRI brain activity using machine learning?\n* Do individuals with BD show more unstable emotional state trajectories (e.g., high metastability, low fractal scaling) than healthy controls?\n* Does amplifying positive emotions stabilize brain and emotional dynamics in BD?\n\nResearchers will compare individuals with bipolar disorder (BD-I or BD-II, currently depressed or mixed state) to healthy controls without psychiatric history to see whether the BD group shows greater fluctuations in emotional brain activity and whether positive emotion regulation strategies normalize this instability.\n\nParticipants will:\n\n* Complete self-report questionnaires on mood, emotion regulation, anxiety, and daily functioning.\n* Recall and provide short descriptions of personal positive and negative memories to be used in the MRI task.\n* Undergo fMRI scanning, including:\n* Resting-state scans\n* A Think and Regulate Affective States Task (TReAT) where they recall autobiographical memories, rate emotions, and practice amplifying positive mood.\n* Structural and diffusion MRI for brain mapping.\n* Receive physiological monitoring (heart rate, respiration) during scanning.\n* Complete post-scan surveys on emotional state and task experience.\n\nThis research will help clarify how the brain supports or disrupts emotional regulation in bipolar disorder and may inform the development of personalized, neurobiologically informed treatments for mood instability.",[29,160],"Healthy (Controls)",[162,163,164,165,166,167],"neuroimaging","fMRI","Bipolar Disorder I","Bipolar Disorder II","machine learning","emotion regulation","2026-04-15",{"date":138,"type":39},{"date":171,"type":39},"2025-10-30",{"date":173,"type":21},"2028-11",{"name":175,"class":46},"Laureate Institute for Brain Research, Inc.",{"id":177,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":179,"briefSummary":25,"conditions":180,"keywords":181,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":186,"leadSponsor":187,"locationsCount":47},"100573024",{"count":20,"type":21},[24],[27,28,29,30],[32,33,34],"2025-07-08",{"date":184,"type":39},"2025-07-11",{"date":41,"type":39},{"date":43,"type":21},{"name":45,"class":46},{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":16,"minAge":195,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":199,"briefSummary":200,"conditions":201,"keywords":202,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":47},"100583919","a-compassionate-focused-intervention-for-older-people-with-bipolar-disorder-100583919","NCT06882590","A Compassionate-focused Intervention for Older People with Bipolar Disorder","A Brief Compassionate-focused Intervention for Older People with Bipolar Disorder","Inclusion Criteria:\n\n* Adults aged 60 years and above.\n* Have a nominated healthcare professional (i.e. GP\u002FCare Coordinator)\n* Meet the criteria for a diagnosis of bipolar disorder I or II according to the MINI.\n* Score of \\>57 on Ruminative Response Scale (RRS)\n* Be able to provide written informed consent.\n* Be able to speak sufficient English to engage in the assessments and intervention.\n\nExclusion Criteria:\n\n* Currently in an episode of mania or hypomania according to the MINI.\n* Experiencing 'severe depression' according to the Hamilton Depression Rating Scale, which equates to a score of over 24.\n* MoCA score of \\\u003C22 to exclude for moderate and severe cognitive impairment.\n* Currently receiving psychological therapy.","60 Years","90 Years",{"count":198,"type":21},6,[128],"The aim of this study is to determine whether it is feasible to deliver a 9-session compassionate-focused therapy for older people with bipolar disorder. Participants will be asked to complete baseline measures and at post-intervention follow-up (12 weeks and 24 weeks) to understand any potential clinical benefits of the therapy.",[29],[203,204,205,206,207,208],"Compassion-Focused Therapy","Older Adults","Rumination","Bipolar Disorder","Guilt","Shame","2025-03-16",{"date":211,"type":39},"2025-03-18",{"date":213,"type":21},"2025-07-01",{"date":215,"type":21},"2026-04",{"name":217,"class":46},"University of Manchester",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":226,"targetDuration":227,"studyType":60,"phases":4,"briefSummary":228,"conditions":229,"keywords":230,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":47},"100526408","the-bipolar-lithium-imaging-scan-study-100526408","NCT06134349","The Bipolar Lithium Imaging Scan Study.","The Bipolar Lithium Imaging Scan Study: Imaging Lithium in the Brains of Subjects with Bipolar Disorder","BLISS","Inclusion Criteria:\n\n1. age 18 years or above,\n2. a clinical diagnosis of bipolar disorder type I or type II ,\n3. having reached stable therapeutic serum lithium concentrations (reference values 0.6-1.0 mM in age to 65 years; 0.4-0.8 in age 65 years and above) within four weeks prior to study participation, and\n4. provided written informed consent.\n\nExclusion Criteria:\n\n1. insufficient comprehension of the Dutch language,\n2. unable to provide informed consent,\n3. drug or alcohol abuse over a period of two weeks prior to study participation, and\n4. meeting any exclusion criterium for MR imaging.",{"count":126,"type":21},"1 Year","The main goal of this study is to determine if brain lithium-concentrations predict clinical lithium treatment-response. Secondary, to study correlations between intracerebral distribution-patterns of lithium with clinical treatment outcome.\n\nBrain lithium concentrations will be measured using ultra-high field (7 Tesla) lithium magnetic resonance (MR) imaging, which has recently been introduced. Determining lithium-concentrations in the brain has been difficult so far due to lithium's relatively low concentration (compared to protons, which are targeted in conventional MRI). 7T lithium MR imaging has the potential to produce much more detailed MR images compared with previous studies, for the first time. The BLISS study is expected to yield new insights, helping to better understand why clinical lithium response varies between individuals.",[29],[67,231,232,233,234,235,236],"lithium","lithium MR imaging","ultra-high field imaging","clinical response","clinical","7 Tesla","2024-12-10",{"date":239,"type":39},"2024-12-13",{"date":241,"type":39},"2024-03-13",{"date":243,"type":21},"2028-03-01",{"name":245,"class":46},"Leiden University Medical Center"]