[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bipolar-disorder-bd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bipolar-disorder-bd":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,35,0,25,[9,49,75,104,129,167,197,217,243,263,294,316,347,374,401,431,457,478,506,530,558,585,619,644,671],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":21,"enrollmentInfo":22,"targetDuration":4,"studyType":25,"phases":26,"briefSummary":28,"conditions":29,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100644218","phase-3-pramipexole-vs-placebo-treatment-in-bipolar-disorder-with-anhedonic-depression-100644218",false,"NCT07664852","Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression","B-HAPPI: Bipolar Disorder and High-dose Adjunctive Pramipexole in Anhedonic Depression - a Phase III, Double-blind, Randomized Controlled Trial","B-HAPPI","Inclusion Criteria:\n\n* The participant has given their written consent to participate in the trial.\n* For WOCBP, adequate contraception should be used (see section 9.6) and a negative pregnancy test is (u-hCG) required. WOCBP: For the purpose of this protocol, a woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.\n* Age ≥18 years ≤80 years.\n* Diagnosis of bipolar disorder type I or II as verified by ICD-11.\n* Ongoing depressive state according to ICD-11 (at least 2 weeks, maximum 18 months).\n* Significant anhedonia, defined as 3 or 4 points on ≥3 items on the SHAPS self-rating scale\n* Minimum score on the MADRS expert rating scale ≥ 20\n* Ongoing treatment with at least one mood stabilising agent (with sufficient antimanic protection as determined by clinical judgment). If treatment with lithium is ongoing, serum levels must be within the reference range of 0.4-0.9. The latest concentration measurement should be within one month before treatment initiation. If treatment is ongoing with a mood stabilising anticonvulsant or an antipsychotic, any dose adjustments made within 4 weeks prior to study start must be reported. Mood-stabilising anticonvulsants and antipsychotics must not be newly initiated within 4 weeks prior to study start. If treatment with antidepressants is ongoing the dose must have been stable for at least 4 weeks.\n\nExclusion Criteria:\n\n* Pregnancy, breastfeeding or planned pregnancy (if female). See also section 8.6 below for clarification.\n* Meets criteria for a mixed episode according to ICD-11.\n* High suicide risk according to the overall clinical assessment of the research physician.\n* Ongoing substance abuse (within 6 months).\n* Ongoing psychotic symptoms.\n* Prior diagnosis of schizophrenia or schizoaffective disorder.\n* Clinical presentation is primarily attributable to a personality disorder.\n* Subject to compulsory psychiatric care (LPT).\n* History of, or strong clinical suspicion of, impulse control disorder (including current binge-eating disorder). A diagnosis of ADHD is not, in itself, an exclusion criterion; however, participants will be excluded if the clinical presentation is primarily characterised by impulse control-related symptoms.\n* Diagnosis of intellectual disability, dementia, cognitive impairment, or other conditions (including those related to the depressive disorder itself) that, in the judgment of the study physician, may substantially impair the participant's ability to understand the study and provide informed consent.\n* Diagnosis of renal failure (eGFR \\\u003C50 ml\u002Fmin\u002F1.73m2) or severe cardiovascular disease (specifically symptomatic heart failure \\>Class II New York Heart Association (NYHA)).\n* Recently started psychotherapy (within 6 weeks) or planning to start such treatment during participation in the trial. Psychoeducational treatment, which is standard care at bipolar units, is not an exclusion criterion.\n* Ongoing treatment with ECT, ketamine or rTMS.\n* Other medical conditions, other ongoing interventions or other concomitant drug treatment (see section 7.3) that, in the opinion of the investigators, may affect the evaluability of the trial or conditions that increase trial risk. For example: Parkinson's disease, hepatic insufficiency, ongoing cancer not in remission for more than one year.\n* Known or suspected allergy to any active substance or excipient in the medicinal product included in the trial.\n* Participation in other treatment studies.\n* Other reason, as assessed by the investigator, that prevents the research participant's participation, such as the risk that the research participant is unable to complete the trial (non-compliance).",true,"ALL","18 Years","80 Years",{"count":23,"type":24},126,"ESTIMATED","INTERVENTIONAL",[27],"PHASE3","Among psychiatric disorders, bipolar disorder stands out due to its alarmingly high suicide rates. This condition presents unique management challenges, especially during its depressive phase, which carries the highest risk of suicide. B-HAPPI is an academic randomized controlled trial to evaluate a new medication for bipolar depression. It will investigate the efficacy and safety of pramipexole, a potent dopamine agonist that has demonstrated significant effectiveness in bipolar disorder in preliminary studies, showing large effect sizes.\n\n* Population: 126 patients with bipolar depression\n* Intervention: Pramipexole added to ongoing treatment with mood stabilizer, flexible dosing - target dose 2.1 mg\u002Fday\n* Control: Add-on identical placebo\n* Outcomes: Primary outcome is change in anhedonia symptoms between baseline and 6 weeks of intervention. Key secondary outcomes include (for example) general depression symptoms and safety measures.\n\nThere will be a 15 weeks open label follow up. If shown to be effective and safe, this intervention could become a key treatment option for bipolar depression, reducing suffering and potentially lowering suicide risk.",[30],"Bipolar Disorder (BD)",[32,33,34,35],"Randomized controlled trial","Pramipexole","Dopamine agonist","Anhedonia","NOT_YET_RECRUITING","2026-06-27",{"date":39,"type":40},"2026-07-01","ACTUAL",{"date":42,"type":24},"2026-09-01",{"date":44,"type":24},"2029-12-31",{"name":46,"class":47},"Daniel Lindqvist","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":25,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":48},"100645239","phase-4-neuromodulation-of-mood-switch-circuitry-in-bipolar-disorder-100645239","NCT07680153","Neuromodulation of Mood Switch Circuitry in Bipolar Disorder","CircuitBD","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form.\n2. Adults of all genders aged 18-70 at the time of screening.\n3. Diagnosis of Bipolar Disorder (by DSM-V criteria)\n4. Depressive symptoms of at least moderate severity (GRID HDRS-17 score \\>= 14 or as determined by expert clinician).\n5. Not currently taking medications for BD OR on a stable dose of medication for at least 1 month prior to screening and plans to remain off medications OR on this stable dose for the duration of participation.\n6. Access to psychiatric care before, during, and after completion of the study.\n7. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.\n8. Proficiency in English sufficient to complete assessments and follow study procedure instructions.\n9. Stated willingness to comply with all study procedures and availability for the duration of the study.\n\nExclusion Criteria:\n\n1. Imminent risk of suicide.\n2. Presence of a primary DSM-5 diagnosis other than bipolar disorder (BD-I or BD-II), or a current comorbid psychiatric disorder that, in the opinion of the investigators, would confound outcome assessment or interfere with safe participation.\n3. History of seizures or any condition \u002F concurrent medication that could notably lower seizure threshold.\n4. Met criteria for any significant substance use disorder (by DSM-V criteria) in the 6 months prior to screening.\n5. History or presence of significant neurological disorder (e.g., traumatic brain injury, stroke, Parkinson's disease or other movement disorder, epilepsy).\n6. History or presence of significant heart condition (e.g., recent myocardial infarction, congestive heart failure \\> stage 2, angina pectoris, bradycardia or tachycardia at the baseline assessment, uncontrolled hypertension).\n7. MRI contraindication, including presence of foreign metal bodies or implants, implanted or conductive objects in or near the head (e.g., stents, deep brain stimulators, vagus nerve stimulators, aneurysm coils, ocular implants, cochlear implants), permanent make-up.\n8. Individuals who are nursing, pregnant, or contemplating pregnancy within the length of study participation.\n9. Abnormal bloodwork for electrolytes, thyroid, or liver function.\n10. History or presence of any disorder or medical condition that, in the opinion of the study team, may compromise, interfere, or limit the individual's ability to complete the intervention or study procedures.","70 Years",{"count":58,"type":24},62,[60],"PHASE4","This study is exploring a new approach to treating depression in people with bipolar disorder (BD). Investigators are testing whether a non-invasive form of brain stimulation can help us understand depressed-to-euthymic mood shifts and their related brain circuits in BD.\n\nInvestigators in this study will use a technique called repetitive transcranial magnetic stimulation, or rTMS. It uses non-invasive magnetic pulses delivered to the scalp to stimulate specific areas of the brain. rTMS is already used to treat depression, and investigators are now studying whether it can be made even more effective for people with bipolar disorder by precisely targeting an individualized brain region for each participant. Participants in this study will receive two courses of rTMS, one active and one placebo (called \"sham\"), in a randomized order so investigators can directly compare the effects. Before treatment, investigators will use brain scans (MRI) to create a personalized map of each participant's brain activity. This lets investigators identify the exact stimulation target most likely to influence the brain circuits involved in BD mood shifts. Investigators will track mood symptoms closely throughout the study to measure what changes.\n\nInvestigators believe that depression in BD is partly driven by disrupted communication between two brain regions involved in processing what feels important or rewarding. Investigators want to find out whether rTMS can restore that communication and whether doing so leads to measurable improvements in depression.",[30,63,64,65],"Bipolar 1 Depression","rTMS","fMRI","2026-06-25",{"date":68,"type":40},"2026-07-02",{"date":70,"type":24},"2026-07",{"date":72,"type":24},"2031-12",{"name":74,"class":47},"Weill Medical College of Cornell University",{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":25,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":48},"100618920","conceptualizing-borderline-personality-disorder-as-a-relationship-use-disorder-100618920","NCT07337889","Conceptualizing Borderline Personality Disorder as a Relationship Use Disorder","TLUR","Inclusion Criteria:\n\n* General : aged 18-45\n* Specific :\n* Borderline personality disorder (BPD)assessed by SCID, without bipolar disorder\n* Bipolar disorder (assessed by SCID), without BPD (evaluated by SCID)\n* Healthy controls with no psychiatric disorders (screened by SCID).\n\nExclusion Criteria:\n\n* Psychotic disorders (evaluated by SCID)\n* lack of informed consent\n* Not affiliated with social security\n* Under judicial or administrative confinement or involuntary hospitalization\n* Protected by law (e.g., under guardianship)\n* Pregnancy or breastfeeding\n* Inability to understand, speak, or write in French\n* Inability to understand the study's purpose or methodology\n* Excluded from another study during the exclusion period\n* Participants who have received over €6000 in annual indemnities\n* For Bipolar Participants (without BPD) : Current moderate or severe depressive episode (BDI score \\> 18) or Current hypomanic\u002Fmanic episode (YMRS \\\u003C 12)","45 Years",{"count":84,"type":24},194,[86],"NA","This study aims to explore a novel conceptualization of Borderline Personality Disorder (BPD) as a \"Relationship Use Disorder.\" The research proposes that BPD shares key features with behavioral addictions, specifically addiction to interpersonal relationships. The study builds upon previous findings suggesting that individuals with BPD experience intense emotional dysregulation, including negative self-perception, shame, and a compulsive need for external validation. This addiction to relationships, much like substance use disorders, is thought to contribute significantly to the difficulties faced by these individuals, including interpersonal conflicts, self-destructive behaviors, and emotional instability.\n\nThe study seeks to demonstrate that the relational difficulties central to BPD meet the diagnostic criteria for addiction as defined by the DSM-5. It will also explore how these relational struggles are mediated by dysfunctional self-perception and whether they are linked to behaviors such as compulsive sexual behaviors (CSBD) or suicidal tendencies. Additionally, the research will investigate the relationship between addiction to relationships and neurobiological factors, including endorphin levels, in individuals with BPD compared to those with bipolar disorder and healthy controls. The hypothesis is that individuals with BPD will exhibit higher levels of relationship addiction, with this addiction being tied to their perception of self-worth and emotional experiences in relationships.\n\nThis innovative approach aims to refine the understanding of BPD, reduce stigma, and improve treatment strategies by providing scientific evidence supporting the conceptualization of BPD as a \"Relationship Use Disorder.\"",[89,90,30],"Borderline Personality Disorder","Borderline Personality Disorder (BPD)",[92,93],"borderline personality disorder","relationship-use disorder","RECRUITING","2026-06-18",{"date":97,"type":40},"2026-06-22",{"date":99,"type":40},"2026-06-01",{"date":101,"type":24},"2028-08-01",{"name":103,"class":47},"University Hospital, Montpellier",{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":25,"phases":114,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":125,"leadSponsor":127,"locationsCount":48},"100609181","time-restricted-eating-tre-in-bipolar-disorder-100609181","NCT07211217","Time Restricted Eating (TRE) in Bipolar Disorder","TREBD","Inclusion Criteria:\n\n* Adults (aged 18-65 years)\n* Diagnosed with bipolar disorder (i.e., subtype Bipolar I or II as assessed with the Quick SCID)21\n* Currently experiencing depression (i.e., PHQ-9 ≥ 10)22\n* Currently overweight (i.e., Body mass index (BMI) \\> 30 kg\u002Fm2)\n* Provides Informed Consent\n\nExclusion Criteria:\n\n1. Dietary factors:\n\n   1. Diagnosis, or strong clinical suspicion, of eating disorders, including but not limited to, anorexia nervosa, bulimia nervosa, binge eating disorder (as assessed with the Quick SCID)\n   2. Concurrent dietary intervention or modification unrelated to study procedures\n2. Psychiatric factors:\n\n   1. Severe depression (i.e., PHQ-9\\>20)\n   2. Experiencing manic symptoms (i.e., ASRM \\\u003C 6)23\n   3. Active suicidal ideation (i.e., PHQ-9, item 9 \\>2)\n   4. Current alcohol\u002Fsubstance use disorder (as assessed with the Quick SCID)\n3. Medical factors:\n\n   1. Use of weight loss medications or supplements\n   2. Use of medications that may cause weight loss or gain, unless body weight and medication usage remained stable for at least 6 months\n   3. Previous weight loss surgery\n   4. Malignancy within past 2 years\n   5. Major surgery within past 3 months\n   6. Medical instability considered to interfere with study procedures\n   7. Use of medications that have the potential to cause hypoglycemia (e.g., insulin, sulfonylureas)\n   8. Undergoing treatment for cancer\n   9. Use of medications for which time restricted eating would interfere with recommended timing of medication ingestion with food intake.\n4. Lifestyle and other factors:\n\n   a. Work or social schedules that would impede ability to adhere to study protocol\n5. Adherence factors:\n\n   1. Ability to adhere to study procedures","65 Years",{"count":113,"type":24},40,[86],"This is a randomized controlled trial investigating the effects of an 8-TRE intervention compared to a wait list (control) on metabolic health and body composition in people diagnosed with BD and who are currently obese and at least mildly depressed. Following a 1-week baseline assessment, participants will be randomized to either a TRE or the wait list (1-to-1 ratio) for 8 weeks. At baseline, Week 8 (post treatment), and Week 20 (follow-up), investigators will assess daily eating patterns for one week, followed by collection of fasting lipids, body weight and vital signs. At Week 4 (i.e., mid-treatment), the investigators will assess self-reported outcomes only. Participants assigned to the wait list condition will have the option of receiving the TRE intervention after 20 weeks.",[30,117,118],"Bipolar Disorder Depression","Overweight (BMI > 30)",[120],"Time Restricted Eating","2026-06-12",{"date":123,"type":40},"2026-06-15",{"date":123,"type":24},{"date":126,"type":24},"2027-09-30",{"name":128,"class":47},"Massachusetts General Hospital",{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":25,"phases":139,"briefSummary":140,"conditions":141,"keywords":150,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":48},"100640612","flumazenil-for-benzodiazepine-reversal-in-electroconvulsive-therapy-100640612","NCT07619092","Flumazenil for Benzodiazepine Reversal in Electroconvulsive Therapy","Flumazenil for Benzodiazepine Reversal in Electroconvulsive Therapy (FLEET): A Randomized Controlled Trial","FLEET","Inclusion criteria:\n\n* Current depressive episode (unipolar or bipolar), corresponding to ICD-10 codes F31.3-5, F32 or F33.\n* Admitted at a study affiliated department in the Mental Health Services of the Capital Region of Denmark\n* Referred to ECT by the regular psychiatrist and has given consent to ECT\n* Currently receiving treatment with a benzodiazepine and\u002For zopiclone, at a minimum daily dose equivalent to 0.5 mg lorazepam.\n\nExclusion criteria:\n\n* Involuntary treatment with ECT\n* Known gross abnormalities in brain structure deemed likely to influence cognitive functioning\n* Pregnancy or breast-feeding\n* Inability to read or understand Danish\n* Acute organic brain disease (e.g., delirium) influencing the ability to give informed consent\n* Any pre-existing condition associated with an increased risk of prolonged or uncontrollable seizures, including but not limited to epilepsy or alcohol- or benzodiazepine withdrawal states\n* Conditions associated with reduced metabolism of flumazenil (e.g., liver failure)",{"count":138,"type":24},145,[86],"The goal of this study is to investigate whether administering flumazenil to reverse the effects of benzodiazepines and\u002For zopiclone during electroconvulsive therapy (ECT) can help reduce cognitive side effects without diminishing treatment effectiveness in hospitalized patients with depression.\n\nThe investigators hypothesize that blockade of the GABA receptor with flumazenil will reduce cognitive side effects through improved seizures and a reduced need for electrical charge escalation during the ECT series. Cognitive side effects will be measured by the total score on the Screening for Cognitive Impairment in Psychiatry (SCIP) (primary outcome) at follow-up after completion of the ECT series. Furthermore, it is expected that the flumazenil strategy will reduce pre-treatment anxiety and improve patient satisfaction (secondary outcomes). In addition, flumazenil strategy is hypothesized to have beneficial effects on subjective cognitive complaints, autobiographical memory, and executive functioning (secondary outcomes). Finally, the flumazenil strategy is expected to be associated with more favorable structural and functional changes in executive functioning and memory-related brain networks after completion of the ECT series, which may, in turn, be linked to better overall cognition and autobiographical memory (secondary outcome measures). For exploratory purposes, the study will also examine longitudinal changes in depressive symptoms and cognitive outcomes from baseline to follow-up (tertiary outcomes).\n\nInvestigators will compare two different pre-ECT benzodiazepine management strategies:\n\n1. Flumazenil strategy (experimental): continued benzodiazepine and\u002For zopiclone use up until the time of the ECT session, followed by administration of flumazenil immediately prior to ECT\n2. Benzodiazepine withholding strategy (treatment as usual):\n\ndiscontinuation of benzodiazepines and\u002For zopiclone prior to the ECT in accordance with standard clinical practice",[142,30,143,144,145,146,147,148,149],"Depression - Major Depressive Disorder","Functional Magnetic Resonance Imaging (fMRI)","Cognition","Autobiographical Memory","Electroconvulsive Therapy","ECT","Treatment Outcome","Inpatients",[151,152,153,154,155,156,149,157,158,148,144],"flumazenil","benzodiazepine reversal","electroconvulsive therapy","randomized controlled trial","functional magnetic resonance imaging","Autobiographical Memory Test (AMT)","Major Depressive Disorder","Bipolar Disorder","2026-05-27",{"date":99,"type":40},{"date":162,"type":40},"2026-01-15",{"date":164,"type":24},"2028-08",{"name":166,"class":47},"Anders Jørgensen",{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":18,"sex":19,"minAge":175,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":179,"conditions":180,"keywords":184,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":48},"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","7 Years",{"count":177,"type":24},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.",[30,181,182,183],"Bipolar Disorder I or II","Bipolar Disorder Family Members","Screening Tool",[185,186,187,188],"bipolar disorder","bipolar I","bipolar II","bipolar disorder screening",{"date":190,"type":40},"2026-06-03",{"date":192,"type":40},"2026-03-11",{"date":194,"type":24},"2027-07-31",{"name":196,"class":47},"University of Texas Southwestern Medical Center",{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":82,"enrollmentInfo":204,"targetDuration":4,"studyType":25,"phases":206,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":48},"100638963","research-on-the-efficacy-and-safety-of-targeted-suprachiasmatic-nucleus-electrical-stimulation-for-improving-metabolic-disorders-in-patients-with-stable-bipolar-disorder-comorbid-with-obesity-100638963","NCT07589647","Research on the Efficacy and Safety of Targeted Suprachiasmatic Nucleus Electrical Stimulation for Improving Metabolic Disorders in Patients With Stable Bipolar Disorder Comorbid With Obesity","Research on the Efficacy and Safety of Targeted Suprachiasmatic Nucleus Electrical Stimulation for Improving Metabolic Disorders in Patients With Stable Bipolar Disordercomorbid With Obesity","Inclusion Criteria:\n\n1. Both biological parents are of Han ethnicity;\n2. Age range: 18 to 45 years old, gender not restricted;\n3. Meets the clinical diagnostic criteria for bipolar disorder as stipulated in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);\n4. Body Mass Index (BMI) ≥ 28 kg\u002Fm2, or for males, waist circumference ≥ 90 cm and for females, waist circumference ≥ 85 cm;\n5. HAMD-24 score \\\u003C 7 points, YMRS score \\\u003C 5 points;\n6. All included researchers and their family members have given informed consent for this study.\n\nExclusion Criteria:\n\n221\u002F5000\n\n1. Individuals with other DSM-5 spectrum disorders;\n2. Mental disorders caused by substance abuse (such as alcohol, drugs, etc.), and those with severe physical illnesses;\n3. Those who consumed food or microecological preparations containing probiotics, prebiotics, etc. within one week before enrollment, and had a history of respiratory, urinary, digestive system infections and antibiotic use within one month before enrollment;\n4. Those currently having serious suicidal thoughts or behaviors, or those with severe agitation;\n5. Those who cannot follow medical advice for treatment, or those without guardians;\n6. Pregnant or lactating women, or those planning to become pregnant;\n7. Those who cannot complete MRI examinations due to special conditions such as having metal implants or pacemakers in their bodies.",{"count":205,"type":24},70,[86],"This study aims to stabilize the patients with bipolar disorder (BD) comorbid with obesity in the stable phase by using temporal interference stimulation (TIS ) intervention. It intends to investigate the changes in key metabolic molecules such as GLP-1 circadian rhythm, and further explore the molecular mechanism of their metabolic disorders.",[30],"2026-05-24",{"date":159,"type":40},{"date":212,"type":40},"2026-04-27",{"date":214,"type":24},"2027-03-31",{"name":216,"class":47},"First Affiliated Hospital of Zhejiang University",{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":111,"enrollmentInfo":225,"targetDuration":4,"studyType":25,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":242},"100639056","personalized-pharmaco-lifestyle-interventions-for-severe-mental-illnesses-lifetrain-100639056","NCT07586150","Personalized Pharmaco-Lifestyle Interventions for Severe Mental Illnesses (LIFETRAIN)","Personalised Pharmaco-Lifestyle Interventions for Severe Mental Illnesses Enhanced by Digital Health and Immersive Technologies","LIFETRAIN","Inclusion Criteria:\n\n* Age 18 to 65 years\n* Able and willing to provide written informed consent\n* Diagnosis of schizophrenia, bipolar disorder, or major depressive disorder according to DSM-5-TR, confirmed by M.I.N.I.\n* Female participants of childbearing potential must agree to use an effective method of contraception\n* Stable psychopathology defined as BPRS less than or equal to 41, MADRS less than or equal to 34, and YMRS less than or equal to 25, with stable psychopharmacological treatment for at least 2 weeks\n* Reduced functioning at screening defined as SF-36 score less than or equal to 40\n* If using benzodiazepines, dose less than or equal to 2 mg lorazepam equivalent per day\n* Stable somatic condition for at least 4 weeks\n* For semaglutide treatment: overweight with BMI at least 27 and less than 30 kg\u002Fm² plus at least one weight-related risk condition, or obesity with BMI at least 30 kg\u002Fm²\n* For optional adaptive neurostimulation: MADRS score at least 19\n* Expected ability to comply with study procedures in the investigator's judgment\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Current or past neurological disorder or structural brain pathology that may affect study procedures\n* Known intolerance or hypersensitivity to semaglutide\n* Pregnancy or lactation\n* Serious suicidal risk\n* Substance dependence within the last 3 months\n* BMI less than 18.5 kg\u002Fm²\n* eGFR less than 30 mL\u002Fmin\u002F1.73 m²\n* Type 1 diabetes, diabetic ketoacidosis, diabetic retinopathy, or poorly controlled diabetes with recurrent hypoglycemic episodes\n* Pancreatitis, history of pancreatitis, or pancreatic cancer\n* Multiple endocrine neoplasia type 2 or personal\u002Ffamily history of medullary thyroid cancer\n* Pre-existing significant gastrointestinal conditions such as inflammatory bowel disease or gastroparesis\n* Need for acute surgery\n* Other medical condition that may affect study procedures or participant safety\n* For optional adaptive neurostimulation: nonremovable metal in or around the head, known increased intracranial pressure due to infarcts or trauma, professional metal work or prior ocular metal injury, history of rTMS or ECT, or current (es)ketamine treatment",{"count":226,"type":24},140,[86],"This randomized, rater-blind, multicenter clinical trial will evaluate whether a personalized pharmaco-lifestyle intervention improves mental functioning in adults with severe mental illness, including schizophrenia, bipolar disorder, or major depressive disorder. Participants will be randomized to either a modular individualized intervention program or a structured psychoeducation control condition. The individualized intervention may include physical exercise, an anti-inflammatory diet, sleep intervention, social prescribing, semaglutide for eligible participants with overweight or obesity, and optional closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms. The primary outcome is change in the SF-36 Mental Component Summary score from baseline to Month 3.",[230,231,30,232],"Severe Mental Illness","Depression \u002F Major Depressive Disorder","Schizophrenia","2026-05-07",{"date":235,"type":40},"2026-05-14",{"date":237,"type":24},"2028-10",{"date":239,"type":24},"2030-12",{"name":241,"class":47},"Ludwig-Maximilians - University of Munich",5,{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":249,"enrollmentInfo":250,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":48},"100638677","an-exploratory-study-on-the-prediction-of-recurrence-risk-of-bipolar-disorder-using-sentiment-analysis-technology-based-on-multi-modal-feature-fusion-100638677","NCT07573839","An Exploratory Study on the Prediction of Recurrence Risk of Bipolar Disorder Using Sentiment Analysis Technology Based on Multi-modal Feature Fusion","Patients group inclusion criteria:\n\n* Patients who have previously met or currently meet the diagnostic criteria for bipolar disorder according to DSM-5, whose condition and treatment are currently stable, and who cooperate with the assessment;\n* Age ≥18 years, \\\u003C65 years;\n* Han Chinese ethnicity;\n* Sufficient visual and auditory abilities to complete the necessary examinations for the study;\n* Understanding the study content and signing the informed consent form. If the patient is unable to sign the informed consent form personally due to low education level or other reasons, it may be signed by a relative or guardian on their behalf.\n\nexclusion criteria:\n\n* The presence of intellectual disability or other conditions that significantly affect the patient's current mental state;\n* the patient has a serious or unstable physical illness, including: neurological disorders (delirium, dementia, stroke, epilepsy, migraine, etc.), congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, hypertension (including untreated or uncontrolled hypertension), malignant tumors, immunodeficiency, and blood glucose levels higher than 12 mmol\u002FL; or other diseases that may interfere with the test assessment (abnormal indicators more than twice the normal value).\n\nHealthy controls group inclusion criteria:\n\n* Age ≥ 18 years, \\\u003C 65 years;\n* Han Chinese ethnicity;\n* Gender matched to the patient group;\n* Sufficient visual and auditory ability to complete the necessary examinations for the study;\n* Understanding of the study content and signing of informed consent;\n* No family history of mental illness. exclusion criteria:\n* Individuals with a mental disorder conforming to DSM-5, or those with suspicious mental symptoms but not meeting the diagnostic criteria;\n* Individuals with severe physical illness that makes it difficult to complete the necessary examinations.","64 Years",{"count":251,"type":24},400,"Bipolar disorder (BD) has become a significant public health problem with complex clinical manifestations, difficult treatment, and poor prognosis. However, there is still a lack of effective biological markers for diagnosing and predicting recurrence. Sentiment analysis computing usually refers to using machine equipment to classify, identify, interpret, and imitate human emotions. However, current multi-modal emotion analysis research is mainly based on one or two modalities. Due to the diversity and complexity of patients' emotional expressions, this single- and dual-modal information analysis is far from enough for accurate discrimination of emotional symptoms. Only emotion analysis technology based on multi-modal feature fusion can make more precise and effective judgments. The current project is based on our previous research on cognitive neuroimaging and big data analysis of bipolar disorder. The investigators plan to enroll 200 BD patients who meet DSM-5 diagnostic criteria and 200 healthy controls. The investigators will use sentiment analysis technology with multi-modal feature fusion (text data, audio and visual modalities, eye movements, and electrophysiology) to identify BD recurrence. Biological markers for risk prediction and an algorithm model for joint judgment of multi-source information will be established to analyze the characterization data. The effectiveness of this recurrence prediction model will be further verified and optimized through a large-sample, prospective cohort study design. It is hoped that it can provide a new method for predicting the recurrence risk of BD patients. In the near future, clinical decision-making aids based on this auxiliary method can be developed, and the translational application value of clinical diagnosis and treatment can be explored.",[30,254],"Healthy Control","2026-05-01",{"date":233,"type":40},{"date":258,"type":24},"2026-04",{"date":260,"type":24},"2027-12",{"name":262,"class":47},"Shanghai Mental Health Center",{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":56,"enrollmentInfo":271,"targetDuration":4,"studyType":25,"phases":273,"briefSummary":275,"conditions":276,"keywords":281,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":290,"leadSponsor":292,"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).",{"count":272,"type":24},120,[274],"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",[90,277,278,279,30,181,280],"Treatment-Resistant Major Depressive Disorder","Treatment-resistant Bipolar Depression","Major Depressive Disorder (MDD)","Suicidal Ideation",[282,283,89,284,30,279,285],"Dialectical Behavioural Therapy (DBT)","ketamine","Treatment-Resistant Depression","Suicidality","2026-04-28",{"date":288,"type":40},"2026-05-06",{"date":99,"type":24},{"date":291,"type":24},"2029-08",{"name":293,"class":47},"Joshua Rosenblat",{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":25,"phases":304,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":48},"100635746","a-study-of-home-use-brain-stimulation-to-treat-bipolar-depression-100635746","NCT07556692","A Study of Home-use Brain Stimulation to Treat Bipolar Depression","Home-based Transcranial Direct Current Stimulation in Bipolar Depression: a Randomised, Double-blind, Placebo-controlled Trial","BDEP","Inclusion Criteria:\n\n1. Adults aged 18 years or over.\n2. Diagnosis bipolar disorder in a current depressive episode based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria assessed by structured clinical assessment, Mini-International Neuropsychiatric Interview (MINI) (Sheehan et al.,1998).\n3. Having at least a moderate severity of depressive symptoms as measured by a score of at least 18 in MADRS (Montgomery and Åsberg, 1979).\n4. Either not taking antidepressant medication or taking a stable dose of antidepressant medication for at least 6 weeks before enrolment.\n5. Either not currently in psychotherapy or in ongoing psychotherapy for at least 6 weeks before enrolment.\n6. Being under care of GP.\n7. Agreeable for GP to be regularly informed by research team about participation.\n8. Able to provide written, informed consent.\n\nExclusion Criteria:\n\n1. Significant suicide risk as measured by answering 'yes' to questions 4, 5 or 6 on the Columbia Suicide Severity Rating Scale (C-SSRS) Screen (Posner et al., 2011).\n2. Primary comorbid psychiatric disorder (e.g. obsessive compulsive disorder) based on DSM criteria as assessed in MINI (Sheehan et al., 1998).\n3. Having a Young Mania Rating Scale (Young et al., 1978) score of 20 or more.\n4. Current daily use of medications that affect cortical excitability (e.g. benzodiazepines).\n5. Current illicit drug use or heavy alcohol use with high risk of alcohol use disorder as measured by a score of \\> 8 in Alcohol use disorders identification test consumption (AUDITC) (Khadlesari et al., 2017; NICE, 2023).\n6. History of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), other brain stimulation, or psychosurgery for depression.\n7. History of esketamine \u002F ketamine for treatment of depression.\n8. Medical disorder that may mimic mood disorder (e.g. hormonal disorder).\n9. History of myocardial infarction, coronary artery bypass graft (CABG), coronary heart failure (CHF), or history of other cardiac issues.\n10. Have cognitive impairment (e.g. dementia).\n11. History of a neurological disorder (e.g., cerebrovascular events, stroke, structural lesion, epilepsy, seizures, Parkinson's disease).\n12. History of migraines or intractable headaches.\n13. Implant in brain, neurocranial defect or active implantable medical device.\n14. Shrapnel or any ferromagnetic material in head.\n15. If female and of child-bearing potential, currently pregnant or planning to become pregnant during the study\n16. Concurrent enrolment in another interventional study.",{"count":303,"type":24},212,[86],"Bipolar depression is a long-lasting and disabling condition, and many people continue to experience depressive symptoms despite standard treatments. Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation that uses a very small electrical current applied through the scalp and has shown promise as a treatment for depression. This study aims to find out whether a home-based tDCS device is effective and safe in reducing symptoms of bipolar depression when compared with a placebo (sham) treatment. The study will also look at how acceptable the treatment is to participants and how well people are able to use the device at home.\n\nWho can participate? Adult patients aged 18 years and over who have a diagnosis of bipolar disorder and are currently experiencing a depressive episode.\n\nWhat does the study involve? Participants must meet specific eligibility criteria, which will be assessed by the research team. People who do not meet the study criteria or for whom tDCS is not suitable will not be able to take part. Participants will be randomly assigned to receive either active tDCS or a placebo (sham) treatment. Neither the participant nor the researchers assessing outcomes will know which treatment has been assigned.\n\nParticipants will use a study device at home over a defined treatment period and will complete a series of assessments at set time points. These include clinician-rated interviews and self-reported questionnaires about mood and well-being. Device use and adherence data will be collected electronically. Participants will also be monitored for any side effects throughout their involvement in the study.\n\nAlthough the study is multi-site, participation is primarily remote, with most study activities completed from the participant's home.\n\nWhat are the possible benefits and risks of participating? Participants may experience an improvement in depressive symptoms. Information gained from this study may help improve future treatments for bipolar depression.\n\ntDCS is generally well tolerated. Possible side effects include mild and temporary sensations such as tingling, itching, headache, or skin irritation at the electrode sites. All participants will be monitored for adverse events, and appropriate support will be available if needed.\n\nWhere is the study run from? The study is run from King's College London in collaboration with NHS research sites across the UK.\n\nWhen is the study starting and how long is it expected to run for? April 2026 to October 2027\n\nWho is funding the study? The National Institute for Health and Care Research (NIHR), UK.\n\nWho is the main contact? Professor Cynthia Fu, the Chief Investigator at King's College London, cynthia.fu@kcl.ac.uk",[30],"2026-04-22",{"date":309,"type":40},"2026-04-29",{"date":311,"type":24},"2026-04-24",{"date":313,"type":24},"2027-11-30",{"name":315,"class":47},"King's College London",{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":19,"minAge":323,"maxAge":324,"enrollmentInfo":325,"targetDuration":4,"studyType":25,"phases":327,"briefSummary":328,"conditions":329,"keywords":333,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":346},"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":326,"type":24},80,[86],"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.",[30,330,181,331,332],"Bipolar Disorder NOS","Bipolar Spectrum Disorder","Adolescents",[334,335,336,337],"ketogenic","treatment","diet","keto","2026-04-17",{"date":307,"type":40},{"date":341,"type":40},"2025-03-19",{"date":343,"type":24},"2027-03-19",{"name":345,"class":47},"University of California, Los Angeles",4,{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":25,"phases":355,"briefSummary":356,"conditions":357,"keywords":359,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":369,"leadSponsor":371,"locationsCount":48},"100632204","transcranial-photobiomodulation-for-bipolar-depression-100632204","NCT07510646","Transcranial Photobiomodulation for Bipolar Depression","A Pilot Clinical Trial for the Efficacy and Safety of Transcranial Photobiomodulation (tPBM) in Improving Symptoms of Bipolar Depression","Inclusion Criteria:\n\n* • Diagnosis of bipolar depression\n\n  * Montgomery-Asberg Depression Rating Scale (MADRS) of 24 or higher\n  * Capable of providing consent\n  * Currently inpatient or outpatient\n  * Ability to communicate in spoken and written English fluently enough to complete the required study assessments\n\nExclusion Criteria:\n\n* Currently in manic or mixed episode, as measured by Young Mania Rating Scale (YMRS) more than 8-10\n\n  * Currently psychotic\n  * Judged to be at serious and imminent suicidal risk\n  * Currently has alcohol or substance use disorder (meeting criteria in the past 1 months)\n  * Unstable medical conditions\n  * Inability to consent or to complete study procedures\n  * Changes in medications or use of augmentative devices and other interventions in the 4 weeks prior to the study\n  * Participation in other clinical research trials that may influence primary outcomes or adherence to the proposed study\n  * Current pregnancy or intention to become pregnant",{"count":113,"type":24},[86],"This study the effectiveness and safety of light therapy device targeted at the brain using a wearable device, the Vielight RX Gamma as a treatment for bipolar depression. Up to forty patients with bipolar disorder will be enrolled into the study and will either receive active treatment with the Vielight RX Gamma or sham (inactive device). They will be administered the devices in clinic 5days\u002Fweek for 6 weeks. Changes in disease symptoms, cognitive function, pain, quality of life and rest EEG changes will be assessed.",[358,30,117],"Bipolar",[360,361,362,185,363,364],"photobiomodulation","PBM","Vielight","bipolar depression","light therapy","2026-04-01",{"date":367,"type":40},"2026-04-03",{"date":39,"type":24},{"date":370,"type":24},"2027-07-01",{"name":372,"class":373},"Vielight Inc.","INDUSTRY",{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":382,"enrollmentInfo":383,"targetDuration":4,"studyType":25,"phases":385,"briefSummary":386,"conditions":387,"keywords":389,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":398,"leadSponsor":399,"locationsCount":48},"100553629","program-to-enhance-cardiovascular-risk-trough-an-intervention-of-nutrition-in-bipolar-disorder-100553629","NCT06488573","PROgram To Enhance Cardiovascular Risk Trough an Intervention of Nutrition in Bipolar Disorder","The Effect of a Nutritional Intervention Focused on Dietary Pattern in the Cardiovascular Risks of Individuals With Bipolar Disorder","PROTECTION-BD","Inclusion Criteria:\n\n* Clinical diagnosis of Bipolar disorder types I and II diagnosis\n* Adults of both genders, from 18 to 60 years old\n* In typical pharmacotherapy for BD, for at least one month\n* Agreement to participate in the study with signature of the consent form\n\nExclusion Criteria:\n\n* Patients with \"very good or excellent\" diet quality assessed by the diet quality scale (ESQUADA): \\>275 out of a score of 375\n* Patients in a state of hypomania or mania: score \\>8 (Young Mania Rating Scale - YMRS)\n* Patients with severe depression \\>21 Montgomery-Åsberg Depression Rating Scale\n* Patients at low cardiovascular risk (\\\u003C7 points for men or \\\u003C9 points for women on the Framingham Global Risk Score)\n* Low weight or eutrophic body mass index: \\\u003C25kg\u002Fm² as in similar studies\n* Pregnant or breastfeeding women\n* Patients diagnosed with anorexia and bulimia nervosa\n* Patientes diagnosed with Irritable Bowl Syndrome or other diagnosed conditions that affect the gastrointestinal function","60 Years",{"count":384,"type":24},88,[86],"Individuals with Bipolar Disorder (BD) have twice the risk of being affected by metabolic comorbidities and a 1.8-fold increased risk of mortality from cardiovascular diseases when compared to the general population. These factors are fundamental in the 14-year reduction in the life expectancy of people with TB reported in recent meta-analyses. This occurs mainly due to the increased inflammation associated with the disease, the adverse effects of pharmacological treatments and unhealthy lifestyle habits that are more common in people diagnosed with BD. Nutrition has been studied as an adjunctive treatment in other psychiatric disorders, but there is a lack of studies about the role of nutrition in TB. Considering that diet can impact metabolic health, this randomized controlled study aims to evaluate the effect of a nutritional intervention on cardiovascular risk in patients with TB. The intervention is based on the dietary pattern recommended in the Dietary Guidelines for the Brazilian Population and will be applied by a registered dietitian. According to the literature, the sample size will be 72 individuals with TB (36 in the control group with usual treatment + 36 in the intervention group added to the usual treatment). The intervention will be carried out in 7 individual sessions and 8 group sessions with specific themes. The primary aim of this protocol will be an intervention to contribute to cardiovascular health - verified by serum markers, anthropometric measurements and the Framingham Cardiovascular Risk Score (algorithm used to estimate an individual's 10-year cardiovascular risk). The secondary stages will be the adherence of the intervention and the impact on the quality of life of the participants. The possible positive results of this nutritional intervention can open new clinical perspectives. Meaning that might show that better food choices can protect the cardiovascular health of individuals with TB, leading to a reduction in morbidity and mortality associated with the disease.",[388,30],"Bipolar Depression",[390,391,185,392,393],"nutrition intervention","nutritional psychiatry","dietary intervention","brazilian dietary guideline","2026-02-26",{"date":396,"type":40},"2026-03-02",{"date":258,"type":24},{"date":260,"type":24},{"name":400,"class":47},"University of Sao Paulo",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":25,"phases":411,"briefSummary":412,"conditions":413,"keywords":417,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":4},"100627220","medication-adherence-in-severe-mental-illness-a-promotion-program-100627220","NCT07445802","Medication Adherence in Severe Mental Illness: a Promotion Program","Therapeutic Adherence Promotion Program for Severe Mental Illness: the ADHERA Study Protocol","ADHERA","Inclusion Criteria:\n\n* Diagnosis established using ICD-11 clinical criteria \\[15\\].\n* Aged 18 years or older.\n* Registered on the Patient Portal.\n* With an active prescription for antipsychotic drugs in the MUP (Medication Use Profile).\n\nExclusion Criteria:\n\n* Aged under 18 years old.\n* Unable to provide consent for medical or legal reasons.\n* Not registered on the Patient Portal.\n* No active prescription for antipsychotic drugs in the MUP.",{"count":410,"type":24},1640,[86],"People living with serious mental illnesses such as schizophrenia and bipolar disorder often need long-term medication to stay well. However, many patients have difficulty taking medication regularly, which can increase the risk of relapse, hospitalization, and poorer quality of life. Traditionally, treatment adherence has been measured using self-report questionnaires, which may be influenced by memory or social desirability bias.\n\nWith the recent expansion of electronic prescription systems in Spain, it is now possible to objectively verify whether patients collect their medications from the pharmacy. This provides a new opportunity to better understand and support treatment adherence.\n\nThe ADHERA study will evaluate how well digital self-report questionnaires reflect real medication use compared with electronic dispensing records. We will also explore patient characteristics that may be associated with difficulties in medication adherence. Finally, we will test a new online psychoeducational program-including sessions led by mental health professionals and supported by peer-experience contributors-to determine whether it can help improve adherence.\n\nParticipants with schizophrenia or bipolar disorder who are registered in the hospital's digital patient portal and have active antipsychotic prescriptions will be invited to complete brief adherence questionnaires online. Individuals with signs of reduced adherence will then be invited to take part in a telehealth intervention consisting of ten group sessions, where they will receive information, support, and practical strategies to maintain their treatment plan. Medication adherence will be reassessed after six months.\n\nIf successful, this study may help improve how treatment adherence is measured in clinical practice, guide targeted interventions for individuals at higher risk of non-adherence, and provide evidence for scalable telehealth programs that can be easily implemented in other regions and medical conditions",[414,415,30,416],"Treatment Adherence and Compliance","Severe Mental Disorders","Schizophrenia Disorder",[418,419,185,420,421],"treatment adherence","schizophrenia","electronic health records","medication","2026-02-25",{"date":424,"type":40},"2026-03-03",{"date":426,"type":24},"2026-09",{"date":428,"type":24},"2028-09",{"name":430,"class":47},"Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz",{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":435,"acronym":436,"eligibilityCriteria":437,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":111,"enrollmentInfo":438,"targetDuration":440,"studyType":178,"phases":4,"briefSummary":441,"conditions":442,"keywords":444,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":454,"leadSponsor":455,"locationsCount":4},"100625848","psychobiological-markers-to-improve-diagnosis-and-to-predict-affective-episodes-in-bipolar-disorder-100625848","NCT07427966","Psychobiological Markers to Improve Diagnosis and to Predict Affective Episodes in Bipolar Disorder","MoodCatcher","Inclusion Criteria:\n\nFor all participants:\n\n* Participants must be capable of giving informed consent.\n* Participants must be able to understand and follow the instructions in the project.\n* Access to a smartphone and ability to use a smartphone and actimeter.\n\nFor patients with bipolar disorder\n\n* Confirmed diagnosis of bipolar disorder (type 1 or type 2) according to ICD-10 after completion of an assessment at a psychiatric clinic in the Stockholm Region.\n* Patients must be euthymic (stable and free from affective episodes) at the time of inclusion.\n* Consent for the research team to access relevant clinical data from patient records.\n\nFor patients with recurrent depression\n\n* Confirmed diagnosis of recurrent depression according to ICD-10 after completion of an assessment at a psychiatric clinic in Region Stockholm.\n* Patients must have been referred for diagnostic assessment with the question of bipolar disorder.\n* Patients must be euthymic (stable and free from affective episodes) at the time of inclusion.\n\nExclusion Criteria:\n\nCommon to all participants:\n\n* Active substance abuse or dependence (alcohol or other substances).\n* Neurological disease or cognitive impairment that may affect study results or compliance with study procedures.\n* Inability to use a smartphone and smartwatch as required by the study.\n* Inability to provide valid informed consent.\n* Inability to understand and follow the study instructions (good knowledge of Swedish is required).\n\nFor adults without psychiatric illness:\n\n* Current or previous psychiatric diagnosis.\n\nFor patients with bipolar disorder and patients with recurrent depression:\n\n* Patients who are in an active affective episode (mania, hypomania or depression) at the time of recruitment.",{"count":439,"type":24},600,"12 Weeks","This trial has two studies. In study 1, the investigators will explore the relationships between three psychobiological factors (sleep patterns, motor activity, and decision-making ability). The investigators aim to investigate how these factors interact in BD patients. This understanding will facilitate the distinction of BD patients from patients with recurrent depressive disorder (MDD) and healthy controls.\n\nIn study 2, the investigators will continue following patients with bipolar disorder and use the interplay between the three psychobiological factors to develop early markers of full-blown affective episodes.",[157,443,30],"Mood Disorders",[445,158,446,447,144,448,449],"Mood disorders","Affective disorder assesment","Major depressive disorder","Sleep","Activity","2026-02-17",{"date":452,"type":40},"2026-02-23",{"date":258,"type":24},{"date":239,"type":24},{"name":456,"class":47},"Karolinska Institutet",{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":82,"enrollmentInfo":464,"targetDuration":4,"studyType":25,"phases":465,"briefSummary":466,"conditions":467,"keywords":469,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":48},"100624785","tms-for-improving-cognitive-function-in-bipolar-disorder-100624785","NCT07414147","TMS for Improving Cognitive Function in Bipolar Disorder","Targeting the Primary Visual Cortex-Hippocampus Circuit With Transcranial Magnetic Stimulation to Improve Cognition in Bipolar Disorder: A Randomized Controlled Trial","Inclusion Criteria:\n\n1: Age between 18 and 45 years; 2: Right-handed; 3: Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar disorder and are currently in a stable remission phase; 4: Hamilton Depression Rating Scale 24-item (HAMD-24) score \\\u003C 8; 5: Young Mania Rating Scale (YMRS) score \\\u003C= 7; 6: The participant and his\u002Fher legal guardian are willing to comply with the treatment procedures and provide written informed consent.\n\nExclusion Criteria:\n\n1: Diagnosis of another primary psychiatric disorder judged by the investigators to be the predominant condition, with functional impairment exceeding that attributable to bipolar disorder; 2: Comorbid psychiatric disorders, including obsessive-compulsive disorder, personality disorders, anxiety spectrum disorders, intellectual disability, or substance use (dependence\u002Fabuse); 3: Inability to complete self-report symptom rating scales or the CANTAB cognitive assessment; 4: Prominent suicidal ideation (item 3 of the HAMD-24 \\>= 2); 5: History of severe physical illness or other medical conditions that may affect the central nervous system; 6: Neurological disorders or risk factors for seizures, such as a history of intracranial disease, head injury, abnormal electroencephalogram (EEG) findings, magnetic resonance imaging (MRI) evidence of structural brain abnormalities, or a family history of epilepsy; 8: Contraindications to MRI or transcranial magnetic stimulation, such as the presence of metallic or electronic implants (e.g., intracranial metallic foreign bodies, cochlear implants, cardiac pacemakers, vascular stents); 9: Receipt of electroconvulsive therapy (ECT) within 6 months prior to study enrollment; 10: Currently undergoing transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neuromodulatory interventions; 11: Pregnant or breastfeeding women, and women of childbearing potential with a positive urine pregnancy test.",{"count":384,"type":24},[86],"Bipolar disorder is a highly disabling psychiatric illness, and cognitive impairment is common in patients with bipolar depression as well as during remission, contributing substantially to functional disability and poorer prognosis. Currently, effective interventions specifically targeting cognitive deficits remain limited, highlighting the need for novel treatment strategies. Transcranial magnetic stimulation, a noninvasive neuromodulation technique, has shown potential benefits for depressive symptoms and cognitive functioning. Based on structural and functional neuroimaging evidence, this study proposes an individualized intermittent theta burst stimulation (iTBS) protocol targeting the primary visual cortex (V1) and its functional pathway to the hippocampus, combined with online cognitive training. This randomized, double-blind, parallel-group, sham-controlled trial will enroll 88 patients with bipolar disorder in remission phase and allocate them to active or sham stimulation. The intervention will be delivered over 5 days, with follow-up assessments through 6 weeks. The primary outcome is change in cognitive performance as measured by the Cambridge Neuropsychological Test Automated Battery (CANTAB). Secondary outcomes include changes in clinical symptom ratings, magnetic resonance imaging (MRI) biomarkers, and the incidence of adverse events. This study aims to evaluate the efficacy and safety of this targeted intervention and to provide evidence for precision treatment approaches to cognitive impairment in bipolar disorder.",[30,468],"Cognitive Impairment",[470],"intermittent theta burst stimulation","2026-02-10",{"date":450,"type":40},{"date":474,"type":24},"2026-03-01",{"date":476,"type":24},"2027-04-30",{"name":216,"class":47},{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":19,"minAge":486,"maxAge":487,"enrollmentInfo":488,"targetDuration":4,"studyType":25,"phases":490,"briefSummary":491,"conditions":492,"keywords":493,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":48},"100624011","epigenetic-enhancement-of-cognitive-training-in-aging-mood-disorder-populations-100624011","NCT07404085","Epigenetic Enhancement of Cognitive Training in Aging Mood Disorder Populations","Epigenetic Priming to Enhance Cognitive Training Gains and Neuroplasticity in Middle-age and Older Adults With Past Depression or Bipolar Disorder (EPIC)","EPIC","Inclusion Criteria:\n\n* Confirmed ICD-10 diagnosis of BD or recurrent UD in partial, or full remission (Hamilton Depression Rating Scale-17 items and Young Mania Rating Scale scores ≤14)\n* Subjective cognitive complaints (self-reported: COBRA ≥12) or objectively-verified cognitive impairment (measured using Screening for Cognitive Impairment in Psychiatry SCIP: total score or at least two subscores ≥ 0.5 SD below expected norms)\n* Fluency in Danish language\n\nExclusion Criteria:\n\n* Diagnosis of schizophrenia\n* Neurological disorders (including dementia)\n* Dyslexia\n* Severe Physical illness\n* Kidney disease\n* Cardiovascular disease\n* Diabetes\n* Alcohol or substance abuse\n* Previous severe head trauma\n* History of epilepsy\n* Pregnancy or breastfeeding\n* BMI \\>30\n* Bodyweight \\\u003C 45kg\n* Daily use of benzodiazepines \\> 22.5 mg. oxazepam or \\> 7.5 mg. diazepam per day\n* Serum lithium levels \\> 0.8 mmol\u002FL\n* Received electroconvulsive therapy \\\u003C 2 months prior to participation\n* Hypertension (\\>140 systolic or \\> 90 diastolic mm Hg)","40 Years","75 Years",{"count":489,"type":24},160,[86],"The aim of this clinical trial is to investigate the effects of a three-week virtual reality-based cognitive remediation training (VR-CRT) programme in combination with daily intake of a histone deacetylase inhibitor (HDACi) sodium butyrate on cognition in symptomatically stable patients with mood disorders (depression or bipolar disorder).\n\nThe investigators hypothesize that the VR-based cognitive remediation training (VR-CRT) combined with HDACi butyrate vs. a VR-based control treatment combined with placebo will improve global cognition (primary outcome measure) over three weeks.\n\nSecondly, the investigators hypothesize that VR-CRT with placebo will improve cognition relative to the VR control treatment with placebo, although to a lesser extent than VR-CRT with HDACi butyrate.\n\nThirdly, the investigators hypothesize that the HDACi butyrate with VR control treatment will not produce cognitive improvements relative to placebo with VR control treatment.\n\nFinally, the investigators hypothesize that the combined treatment (VR-CRT + HDACi butyrate) will enhance neuroplasticity (exploratory outcome) vs. VR control with placebo, as indicated by increase in hippocampal volume and\u002For memory-related activity shown with structural and functional MRI.",[30,142,468],[144,494,445,495,496],"Cognitive impairment","Cognitive decline","Neuroplasticity","2026-02-04",{"date":499,"type":40},"2026-02-11",{"date":501,"type":40},"2025-11-14",{"date":503,"type":24},"2028-07-01",{"name":505,"class":47},"Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital",{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":513,"enrollmentInfo":514,"targetDuration":4,"studyType":25,"phases":516,"briefSummary":518,"conditions":519,"keywords":520,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":528,"locationsCount":48},"100623668","phase-1-adaptation-and-validation-of-the-hypomanic-personality-scale-hps-6-to-romanian-100623668","NCT07399626","Adaptation and Validation of the Hypomanic Personality Scale (HPS-6) to Romanian","Adaptation and Validation of the Hypomanic Personality Scale (HPS-6) to Romanian.","Inclusion Criteria:\n\n* 18-50 years of age\n* Not at high risk of suicide (current)\n* Not high SUDs \u002F AUDs (current)\n* Native Romanian speaker\n* Cognitive abilities intact (reading comprehension of items)\n\nExclusion Criteria:\n\n* High risk of suicide (current)\n* High SUDs \u002F AUDs (current)","50 Years",{"count":515,"type":24},50,[517,274],"PHASE1","The HPS-6 (Hypomanic Personality Scale, 6 item version) could prove to be a valuable candidate for screening measures of high risk individuals. In the following study, we aim to validate and adapt the HPS-6 for the Romanian population.",[30],[185,521,522],"manic-depression","cyclothymia","2026-02-03",{"date":471,"type":40},{"date":526,"type":40},"2025-09-22",{"date":70,"type":24},{"name":529,"class":47},"Babes-Bolyai University",{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":536,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":538,"enrollmentInfo":539,"targetDuration":4,"studyType":25,"phases":541,"briefSummary":542,"conditions":543,"keywords":545,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":554,"leadSponsor":556,"locationsCount":48},"100609354","multimodal-intervention-to-support-hospital-to-community-transition-in-bipolar-disorder-100609354","NCT07213492","Multimodal Intervention to Support Hospital-to-Community Transition in Bipolar Disorder","A Bridge to Better Days: A Pilot Study of a Multimodal Intervention to Support the Successful Transition From Hospital to Community Care for People Living With Bipolar Disorder","BTBD","Inclusion Criteria:\n\n* Age: Patient-participants must be between 18 and 35 years old.\n* Diagnosis: Must have been diagnosed with bipolar disorder within the past 24 months.\n* Clinical Features: Must have experienced psychosis and\u002For a lack of insight into their illness at the time of enrollment.\n* Language Proficiency: Must be able to understand and speak English.\n\nExclusion Criteria:\n\n* Severe Psychiatric Conditions: Individuals with a severe psychiatric condition that would prevent them from safely engaging in the intervention.\n* Cognitive or Medical Impairment: Those with significant cognitive impairment or a medical condition that interferes with their ability to participate in psychoeducation or peer-support sessions.\n* Substance Use Disorder: Individuals with an active substance use disorder that may impact adherence to the intervention.\n* Language Barriers: Participants who do not speak English and are unable to engage in study sessions without language support.\n* Concurrent Participation in Similar Programs: Individuals who are already enrolled in another structured psychoeducational or peer-support program that could interfere with study outcomes.","35 Years",{"count":540,"type":24},10,[86],"People with bipolar disorder (BD) are at high risk of relapse following hospital discharge, partly due to a lack of BD-specific expertise and resources within community services required for comprehensive treatment. Although clinical guidelines recommend combining medication and psychosocial support, and research shows that early intervention is associated with improved outcomes, no structured care programs currently exist for individuals in the early stages of BD, contributing to chronic illness progression and preventable hospitalizations. This open-label pilot trial will assess the feasibility, acceptability, and preliminary effectiveness of a structured care pathway to support the transition from hospital to community care. The intervention includes group-based psychoeducation, individual peer support, and personalized support for community healthcare providers to improve illness insight, treatment adherence, and symptom management.",[30,544],"Psychosis",[158,546,547,544,548,549],"Psychoeducation","Insight","Multimodal Intervention","Early-Stage Bipolar Disorder","2026-01-13",{"date":552,"type":40},"2026-01-14",{"date":99,"type":24},{"date":555,"type":24},"2027-05-01",{"name":557,"class":47},"McMaster University",{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":564,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":25,"phases":568,"briefSummary":569,"conditions":570,"keywords":571,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":4},"100615874","anticipating-depressive-and-manic-episodes-in-bipolar-disorders-using-vocal-biomarkers-100615874","NCT07298278","Anticipating Depressive and Manic Episodes in Bipolar Disorders Using Vocal Biomarkers","ANTICIPATING DEPRESSIVE AND MANIC EPISODES IN BIPOLAR DISORDERS USING VOCAL BIOMARKERS","SPEECHBIPO","Inclusion Criteria:\n\n* Adult patient\n* Patient capable of providing informed consent\n* Patient suffering from bipolar disorder according to DSM-5-TR (2022) criteria\n* Patient recently discharged from hospitalization or in remission after a mood episode within the last 12 months, with a MADRS score ≤10 and a YMRS score ≤8, or based on the psychiatrist's subjective evaluation\n* Patient treated with lithium\u002Fantipsychotics\u002Fbenzodiazepines (monotherapy or combination therapy)\n* Patient capable of performing speech assessments and responding to questionnaires on a smartphone\n* Patient able to speak, read, and understand French\n* Patient enrolled in a social security system\n\nExclusion Criteria:\n\n* Patient with a cognitive disorder\n* Patient suffering from a known demential disorder\n* Patient receiving treatment for a known addictive disorder\n* Patient with a condition affecting speech production\n* Patient with a neurological disorder (stroke or neurodegenerative diseases)\n* Patient under legal protection, guardianship, or curatorship\n* Subjects deprived of liberty by judicial or administrative decision\n* Pregnant or breastfeeding women",{"count":567,"type":24},170,[86],"Bipolar disorder (BD) is a chronic, cyclical mental illness affecting over 1% of the global population. It is characterized by alternating episodes of elevated mood and energy (mania or hypomania) and episodes of decreased mood and energy (depression).\n\nManic episodes involve hyperactivity, decreased need for sleep, grandiosity, accelerated speech, and sometimes psychotic symptoms such as hallucinations or delusions. Depressive episodes, in contrast, are characterized by sadness, low energy, social withdrawal, sleep and appetite disturbances, and low self-esteem. Bipolar patients are at very high risk of suicide, with rates up to 20 times higher than in the general population; nearly half will attempt suicide during their lifetime, and 15-20% of these attempts are fatal.\n\nBD is associated with a substantial decrease in quality of life, often greater than that seen in other mood or anxiety disorders. This reduction is primarily driven by depressive symptoms, including residual ones that may persist during remission periods. The frequent comorbidity with anxiety disorders further exacerbates the burden of the illness.\n\nRecently, research has turned toward the concept of the digital phenotype to identify early markers of relapse using passive and continuous monitoring. Among potential digital biomarkers, voice has shown particular promise. Automated speech analysis, combined with machine learning algorithms, has demonstrated effectiveness in detecting psychiatric symptoms and differentiating mood states. In BD, vocal and linguistic patterns vary with mood fluctuations, suggesting that voice could serve as a sensitive indicator of relapse risk.\n\nThe main hypothesis of the present study is that automated analysis of speech and lifestyle data can help develop a predictive model capable of identifying early signs of relapse, whether manic, depressive, or mixed, or transitions to high-risk states in individuals with bipolar disorder.",[30],[572,573,574,575],"Bipolar Disorders","Digital Biomarkers","Speech Analysis","Relapse prediction","2025-12-17",{"date":578,"type":40},"2025-12-23",{"date":580,"type":24},"2025-12-20",{"date":582,"type":24},"2027-05",{"name":584,"class":47},"Centre Hospitalier St Anne",{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":591,"eligibilityCriteria":592,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":593,"targetDuration":4,"studyType":25,"phases":594,"briefSummary":595,"conditions":596,"keywords":599,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":618},"100615672","characterization-of-high-level-cognitive-impairments-in-patients-with-neuropsychiatric-disorders-100615672","NCT07295652","Characterization of High-Level Cognitive Impairments in Patients With Neuropsychiatric Disorders","Characterization of High-level Cognitive Impairments in Patients With Neuropsychiatric Disorders","COGPSY","Inclusion Criteria:\n\nFor patients:\n\n* Aged over 18 years\n* Diagnosed with a psychiatric disorder according to ICD-10 by a psychiatrist (F10-F98) or diagnosed with a neurological disorder according to ICD-10 by a neurologist (G00-G99)\n* Provided written informed consent\n* Affiliated with a social security scheme\n\nFor healthy volunteers:\n\n* Aged over 18 years\n* Provided written informed consent\n* Affiliated with a social security scheme\n\nExclusion Criteria:\n\nFor healthy volunteers:\n\n* Current diagnosis of a psychiatric disorder according to ICD-10 (F20-F98) or current prescription of a psychotropic medication, or diagnosis of a neurological disorder according to ICD-10 (G00-G99)\n* History of depression (F32)\n* Substance use disorder (excluding tobacco)\n* Neurological history (e.g., stroke, coma, epilepsy, neuroinflammatory or neurodegenerative disease) or identified cognitive disorder\n* Inability to complete cognitive testing (e.g., due to motor or sensory impairment)\n\nFor participants undergoing MRI (without contrast agent):\n\n* Presence of MRI contraindications: non-MRI-compatible pacemaker, heart valve, implant, or metallic foreign body\n* Pregnancy at the time of MRI",{"count":439,"type":24},[86],"Neuropsychiatric disorders are extremely common, severe, and disabling conditions. In the field of psychiatry, they notably include schizophrenia, mood disorders (depressive and bipolar disorders), autism spectrum or neurodevelopmental disorders, obsessive-compulsive disorder, eating disorders, and personality disorders. In the field of neurology, one can cite neurodegenerative diseases (such as Alzheimer's disease, but also frontotemporal dementia or Parkinson's disease, which often represent frequent and challenging differential diagnoses of psychiatric disorders), focal neurological lesions (notably strokes and tumors), or epilepsy.\n\nCognitive impairments are present in nearly all neuropsychiatric disorders and contribute significantly to disability.\n\nWhile impairments in working memory and attention, executive functions, and social cognition have been relatively well studied, other cognitive domains remain largely unexplored in these populations. This is particularly the case for various aspects of motivation, metacognition, conscious access, or causal (Bayesian) inference.\n\nAlthough these domains likely play an important role in prognosis, no consensus currently exists regarding the methods for evaluating these functions.\n\nThe main objective of this study is to define a multidimensional, transdiagnostic atlas of high-level cognitive impairments-both specific and shared-across severe psychiatric disorders (notably schizophrenia, depressive disorder, bipolar disorder, autism spectrum or neurodevelopmental disorders, and obsessive-compulsive disorder) and neurological disorders (notably neurodegenerative diseases, focal neurological lesions, and epilepsy), by comparing them to healthy volunteers.\n\nThe investigators also aim to investigate the progression of cognitive impairments over time, across different phases of illness (symptom stabilization or exacerbation) or therapeutic intervention, through longitudinal follow-up of patients being monitored within the recruiting center.\n\nFinally, in a more exploratory manner, the investigators aim to investigate the neural correlates of the identified cognitive impairments.",[597,232,30,598],"Neurologic Disorders","Depressive Disorder",[600,601,602,603,604,605,606,607,608,609],"Cognitive dysfunction","Executive function","Metacognition","Motivation","Social cognition","Transdiagnostic approach","High-level cognition","Longitudinal cognitive changes","Cognitive profiling","Differential diagnosis","2025-12-16",{"date":612,"type":40},"2025-12-19",{"date":614,"type":40},"2024-03-12",{"date":616,"type":24},"2039-03",{"name":584,"class":47},3,{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":4,"eligibilityCriteria":625,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":111,"enrollmentInfo":626,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":628,"conditions":629,"keywords":631,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":635,"lastUpdatePostDateStruct":636,"startDateStruct":638,"completionDateStruct":640,"leadSponsor":642,"locationsCount":48},"100616504","effects-of-schizophrenia-and-bipolar-disorder-on-exercise-capacity-pulmonary-function-and-quality-of-life-100616504","NCT07306468","Effects of Schizophrenia and Bipolar Disorder on Exercise Capacity, Pulmonary Function, and Quality of Life","Investigation of Exercise Capacity, Pulmonary Function, Respiratory Muscle Strength, and Quality of Life in Patients Diagnosed With Schizophrenia and Bipolar Disorder","Inclusion Criteria:\n\n* Being volunteer for participation\n* Being 18 to 65 age\n\nExclusion Criteria:\n\n* Having any respiratory, cardiac, neurologic or orthopedic disease which may affect respiratory functions or exercise capacity\n* Having any neuropsychiatric disease except schizophrenia or bipolar disorder",{"count":627,"type":24},150,"This observational study aims to evaluate exercise capacity, pulmonary function, respiratory muscle strength, and quality of life in individuals diagnosed with schizophrenia and bipolar disorder. These psychiatric conditions are associated with sedentary lifestyles, metabolic side effects of psychotropic medications, and increased comorbidity risks, all of which may negatively impact physical fitness and respiratory health. By assessing cardiorespiratory endurance, pulmonary parameters (FVC, FEV₁), and respiratory muscle strength in this population, the study seeks to identify physiological limitations and contribute to the development of more effective rehabilitation strategies. The findings may support multidisciplinary approaches to improving physical health and overall quality of life in individuals with severe mental illness.",[630,30],"Schizophenia Disorder",[419,185,632,633,634],"respiratory functions","quality of life","exercise capacity","2025-12-14",{"date":637,"type":40},"2025-12-29",{"date":639,"type":40},"2025-11-01",{"date":641,"type":24},"2026-12-01",{"name":643,"class":47},"Çankırı Karatekin University",{"id":645,"slug":646,"hasResults":12,"nctId":647,"briefTitle":648,"officialTitle":649,"acronym":650,"eligibilityCriteria":651,"healthyVolunteers":12,"sex":19,"minAge":652,"maxAge":653,"enrollmentInfo":654,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":656,"conditions":657,"keywords":660,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":669,"locationsCount":48},"100611958","multimodal-phenotyping-in-adolescent-inpatient-depression-an-observational-study-100611958","NCT07247344","Multimodal Phenotyping in Adolescent Inpatient Depression: An Observational Study","Digital Phenotyping and Multimodal Biomarker Discovery for Major Depressive Episodes in Adolescent Inpatients: A Prospective Cohort Study","MAPS-IO","Inclusion Criteria:\n\n* Between 10 and 20 years of age;\n* Diagnosis of major depressive disorder (MDD) or bipolar disorder (BD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). Diagnosis is assessed using the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) for participants aged ≥18 years, or the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K-SADS-PL) for participants aged \\\u003C18 years;\n* Current moderate to severe depressive episode, defined as Hamilton Depression Rating Scale (HAMD) score ≥17;\n* Participants and 1 or 2 parents (patients' age\\\u003C 18 years old) provide informed consent after the detailed description of the study.\n\nExclusion Criteria:\n\n* Prior treatment with repetitive transcranial magnetic stimulation (rTMS), transcranial direct current stimulation (tDCS), electroconvulsive therapy (ECT), or standard psychological therapy within 6 months prior to screening;\n* Comorbidity with other DSM-IV Axis I disorders or personality disorders;\n* Judged clinically to be at serious risk of suicide;\n* Diabetes mellitus, hypertension, vascular and infectious diseases and other major medical comorbidities;\n* Unstable medical conditions, e.g., severe asthma; Neurological disorders, e.g., history of head injury with loss of consciousness for ≥ five minutes, cerebrovascular diseases, brain tumors and neurodegenerative diseases;\n* Mental retardation or autism spectrum disorder;\n* Contraindications to MRI (e.g., severe claustrophobia, pacemakers, metal implants);\n* Current drug or alcohol abuse or dependence;\n* Pregnant or lactating females.","10 Years","20 Years",{"count":655,"type":24},1000,"This cohort study involves the dynamic collection of clinical information from adolescent patients with major depressive episodes (including both major depressive disorder and bipolar disorder), encompassing serum parameters, physiological-behavioral signals, neuroimaging data, and neuropsychological scales. The study aims to summarize the comprehensive clinical characteristics of this population, identify new risk factors, and establish multivariate predictive models for treatment response, cognitive and emotional impairments. Furthermore, this research will thoroughly investigate the underlying neural mechanisms linking clinical manifestations and neuroimaging features in major depressive episodes.",[658,659,30],"Adolescent","Major Depressive Disorder (MDD",[661],"Major Depressive Episode","2025-11-23",{"date":664,"type":40},"2025-11-25",{"date":666,"type":40},"2025-03-01",{"date":668,"type":24},"2029-03",{"name":670,"class":47},"Jiangsu Province Nanjing Brain Hospital",{"id":672,"slug":673,"hasResults":12,"nctId":674,"briefTitle":675,"officialTitle":676,"acronym":677,"eligibilityCriteria":678,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":111,"enrollmentInfo":679,"targetDuration":4,"studyType":25,"phases":680,"briefSummary":681,"conditions":682,"keywords":683,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":691,"startDateStruct":692,"completionDateStruct":693,"leadSponsor":695,"locationsCount":346},"100611376","phase-2-the-pedal-intervention---reducing-affective-lability-in-bipolar-disorder-100611376","NCT07239778","The PEDAL Intervention - Reducing Affective Lability in Bipolar Disorder","The PEDAL Intervention - Reducing Affective Lability in Bipolar Disorder - a Randomised Controlled Trial","PEDAL","Inclusion Criteria:\n\n* Bipolar I, II or not otherwise specified disorder\n* Understands Scandinavian language\n* Owns and will use smartphone as part of the intervention\n* Is considered eligible for group participation by treating clinician\n\nExclusion Criteria:\n\n* Previous participation in group psychoeducation for bipolar disorder\n* Will move, is late in pregnancy or other situation that prevents competion of trial",{"count":272,"type":24},[274],"PEDAL is a group-based intervention for patients with bipolar disorder that builds on the traditional group psychoeducational program (GPP) by adding digital tools and specific strategies to help manage rapid fluctuations between affective states, known as affective lability. The program's goal is to help patients learn and develop new ways to better manage their condition, with particular attention to affective lability and other difficulties with affect regulation- challenges which are not typically addressed in current treatments.\n\nThe PEDAL trial will run at five clinical sites around Oslo and Vestre Viken, aiming to recruit 120 participants with bipolar disorder. The program combines existing group sessions from GPP with new components: additional group sessions focusing on strategies for improving affect regulation such as mindfulness and distress tolerance, an online platform with all course materials including instructional videos and other resources, and an app-based mood diary. This framework maintains the benefits of regular group meetings while adding digital support tools to make the intervention more personalized and accessible.\n\nThe main aim of PEDAL is to see if the new program reduces affective lability more effectively than GPP (treatment-as-usual; TAU), and both intervention groups will be compared on the level of affective lability before and after the intervention. Several secondary outcomes like mood symptoms, suicidal thoughts, perceived stress, and quality of life will also be assessed. In terms of study design, all study sites will run the PEDAL and TAU groups in parallel, and participants will be randomly assigned to either PEDAL or TAU.\n\nTo qualify for the study, participants must be aged 18-65, diagnosed with bipolar disorder, able to participate in a group intervention, capable of providing informed consent, and have a smartphone or computer. People who have previously completed group psychoeducation, who are unable to complete the study period due to pregnancy or other factors, or those who cannot use the required technology are excluded.\n\nIn summary, PEDAL is a novel study that modernizes the existing group psychoeducational program for bipolar disorder by targeting affective lability through skills training and digital tools, while also evaluating its reception and effects in a controlled clinical trial.",[30],[684,685,546,686,687,688,689],"Affective lability","Bipolar disorder","Group intervention","Emotion regulation","Digital tools","eHealth","2025-11-20",{"date":664,"type":40},{"date":664,"type":24},{"date":694,"type":24},"2026-12",{"name":696,"class":47},"Oslo University Hospital"]