[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"depression-bipolar\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:depression-bipolar":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,63,89,119,175,207,234,255,287,312],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":45,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100551600","natural-history-of-depression-bipolar-disorder-and-suicide-risk-100551600",false,"NCT06462196","Natural History of Depression, Bipolar Disorder and Suicide Risk","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Signed consent for Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers\n* Age 18 years or older\n* Able to provide informed consent\n* Able to read and write English\n\nEXCLUSION CRITERIA:\n\n* Unstable medical conditions in the opinion of the investigator that would preclude participation in outpatient or inpatient treatment.\n* Pregnancy\n* Participation in the Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers, as a healthy volunteer.\n* Participants with a history of DSM-IV substance or alcohol abuse or dependence, or DSM-5 substance use disorder (except for caffeine, nicotine, or cannabis), or moderate to severe alcohol use disorder, within the preceding three months. In addition, participants who are currently using drugs (except for caffeine, nicotine, or cannabis) must not have used illicit substances or known drugs of abuse in the two weeks prior to consent and must have a negative drug urine test (except for prescribed benzodiazepines or stimulants) prior to enrolling in the study. Cannabis use is exclusionary if the use is daily, or if participants are unable to abstain during the study, or if function of daily life is impaired by use as determined by a clinician.","ALL","18 Years","120 Years",{"count":19,"type":20},500,"ESTIMATED","OBSERVATIONAL","Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide.\n\nPeople 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254.\n\nThis study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time.\n\nParticipants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation.",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Behavioral Symptoms","Suicide","Self-Injurious Behavior","Sensory System Agents","Analgesics","Peripheral Nervous System Agents","Physiological Effects of Drugs","Anesthetics, Dissociative","Anesthetics, General","Anesthetics","Central Nervous System Depressants","Excitatory Amino Acid Antagonists","Excitatory Amino Acid Agents","Neurotransmitter Agents","Molecular Mechanisms of Pharmacological Action","Ketamine","Depression, Unipolar","Depressive Symptoms","Treatment Resistant Depression","Major Depressive Disorder","Depression, Bipolar",[46,25,43,47,48,49,42],"Neurobiology","Bipolar Disorder","Biomarkers","Suicide Risk","RECRUITING","2026-06-26",{"date":53,"type":54},"2026-06-29","ACTUAL",{"date":56,"type":54},"2024-09-09",{"date":58,"type":20},"2030-06-01",{"name":60,"class":61},"National Institute of Mental Health (NIMH)","NIH",1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":62},"100509478","phase-4-lithium-versus-cariprazine-in-the-acute-phase-treatment-of-bipolar-depression-duag9-100509478","NCT05913947","Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)","Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression: a Pragmatic Head-to-head Open, Randomized Multicenter Study: The 9th Study of the Danish University Antidepressant Group (DUAG 9)","DUAG9","Inclusion Criteria:\n\n* A diagnosis of bipolar disorder, type 1 or type 2, and a current episode of depression according to DSM-5\n* Severity of depression: A score of at least 21 on the self-reported Major Depression Inventory (MDI).\n* No start or dose increase of psychotropic medication (except for benzodiazepines and benzodiazepine-like drugs (zopiclone, zolpidem, and melatonin)) in the two weeks prior to inclusion.\n* No new start of formalized psychotherapy sessions, excluding psychoeducation, during the 4 weeks prior to inclusion.\n* Age criteria: Subjects must be at least 18 years old and below 65 at the time of randomization.\n* The duration of the current depressive episode must be between 4 and 52 weeks as judged by the investigator at the time of randomization.\n* Clinical uncertainty regarding which of the alternatives, cariprazine and lithium, would be the better choice in the specific case.\n* Female participants should be sterile or non-fertile or, in case of being fertile, they must have a negative pregnancy test AND use safe anticonception.\n* Signed document of informed consent.\n\nExclusion Criteria:\n\n* Prior or ongoing acute treatment of a depressive episode lasting \\> 14 days with either lithium or cariprazine as judged by the investigator.\n* ECT within the current depressive episode.\n* A score of MAS \\> 6.\n* A diagnosis of dementia.\n* High risk of non-adherence at the investigator's discretion.\n* Not understanding the Danish language as judged by the investigator\n* Psychiatric coercion in the form of forced admission or detainment OR sentence to forensic psychiatric care.\n* Presence of clinically relevant delusions, hallucinations or other psychotic symptoms as judged by the investigator.\n* Suicidality according to C-SSRS with a positive response to question 4 or 5 or upon investigator's discretion.\n* Medical conditions like cancer, kidney failure, epilepsy, deep brain stimulation device, or other medical conditions interfering with study the outcome and safety as judged by investigator's discretion.\n* Current harmful use or dependency of alcohol or drugs according to DSM-5.\n* Known allergy to any of the substances in the study medication.","65 Years",{"count":73,"type":20},122,"INTERVENTIONAL",[76],"PHASE4","The goal is to study the effect of lithium compared to cariprazine in patients with depression in a bipolar disease.\n\nThe main question it aims to answer is:\n\nDifference in change between the two groups from baseline to after 8 weeks treatment on Hamilton Ratings Scale for Depression, 6-item version (HDS-6)\n\nParticipants will be randomized to treatment with either lithium or cariprazin.\n\n* Will meet for interview and ratings 4 times during study period.\n* In two meetings, there will be made blood samples and ECG. At one meeting also a Urine sample.\n* Will be contacted for telephone interviews at 6 occasions.",[44],"2026-01-19",{"date":81,"type":54},"2026-01-21",{"date":83,"type":54},"2022-12-13",{"date":85,"type":20},"2028-09-02",{"name":87,"class":88},"Aalborg University Hospital","OTHER",{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":74,"phases":98,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"100594977","phase-4-right-sided-1-hz-repetitive-transcranial-magnetic-stimulation-rtms-versus-left-sided-intermittent-theta-burst-stimulation-itbs-in-patients-with-depression-100594977","NCT07026461","Right-sided 1-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) Versus Left-sided Intermittent Theta Burst Stimulation (iTBS) in Patients With Depression","Right-sided 1-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) Versus Left-sided Intermittent Theta Burst Stimulation (iTBS) in Patients With Depression. -a Randomized Non-inferiority Trial","Inclusion Criteria:\n\n* At least 18 years of age at the time of inclusion.\n* A clinical diagnosis of unipolar or bipolar depression according to ICD-10.\n* Acceptance of rTMS.\n* A Swedish personal identity number.\n* Capable of giving informed consent.\n\nExclusion Criteria:\n\n• If the investigator judges one of the two treatment protocols inappropriate for the patient.",{"count":97,"type":20},350,[76],"Aim: The purpose of the study is to establish the non-inferiority of right-sided inhibitory 1 Hz stimulation compared to left-sided intermittent theta burst stimulation (iTBS) in unipolar and bipolar depression.\n\nDesign: A national, non-inferiority, register-based, randomized trial, unmasked, with two treatment arms.\n\nPrimary objective: The primary objective is to determine if right-sided inhibitory 1-Hz stimulation to dorsolateral prefrontal cortex (DLPFC) is non inferior to iTBS in treating unipolar and bipolar depression by measuring reduction in Montgomery-Åsberg Depression Rating Scale, self-assessed version (MADRS-S) from baseline to end of treatment.\n\nSecondary objectives: Include testing for differences in:\n\n* Observer rated response according to Clinical Global Impression Scale-Improvement (≥2 point reduction CGI).\n* Response to treatment (a decrease of 50% on MADRS-S)\n* Self-rated global health measured with the EuroQual-group 5 Dimensions Scale Visual Analogue Scale (EQ-5D-VAS).\n* Drop-out from treatment.\n* Stimulation site pain measured with the Numerical Rating Scales (NRS).\n* Adverse events.\n* Admission and suicides within 6 months.\n* New treatment course of rTMS or ECT within 6 months\n* Remission (score \\\u003C 11 on the MADRS-S)\n* Memory impairment measured with the Comprehensive Psychopathological Rating Scale (CPRS).\n\nStudy population: Patients with unipolar or bipolar depression. Sample size: 350 patients.\n\nInclusion criteria:\n\n* At least 18 years of age at the time of inclusion.\n* A clinical diagnosis of unipolar or bipolar depression according to ICD-10.\n* Acceptance of rTMS.\n* A Swedish personal identity number.\n* Capable of giving informed consent.\n\nExclusion criteria:\n\n• If the investigator judges one of the two treatment protocols inappropriate for the patient.\n\nInclusion time: 2025-07-01 to 2029-01-01",[101,102],"Depression - Major Depressive Disorder","Depression Bipolar",[104,105,106,107,108],"rtms","itbs","repetitive transcranial magnetic stimulation","randomized controlled trial","intermittent theta-burst stimulation","2025-12-08",{"date":111,"type":54},"2025-12-16",{"date":113,"type":20},"2025-12-15",{"date":115,"type":20},"2031-12-31",{"name":117,"class":88},"Region Örebro County",2,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":129,"conditions":130,"keywords":149,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"100609246","precision-subclassification-of-mental-health-in-diabetes-digital-twins-for-precision-mental-health-to-track-subgroups-100609246","NCT07212075","Precision Subclassification of Mental Health in Diabetes: Digital Twins for Precision Mental Health to Track Subgroups","TwinPeaks","Inclusion Criteria:\n\n* 18 to 80 years of age\n* Diagnosis of type 1 diabetes or type 2 diabetes or other specific type of diabetes\n* Diabetes duration ≥ 1 year\n* Sufficient German language skills\n* Informed consent\n\nExclusion Criteria:\n\n* Inability to consent\n* Significant cognitive impairment (e.g. dementia)\n* Severe disorder or condition impacting the person's ability to participate in the study or likely to confound results (e.g. treated cancer, heart disease ≥ NYHA III, schizophrenia\u002Fpsychotic disorder)\n* Terminal illness\n* Being bedridden","80 Years",{"count":128,"type":20},1809,"Mental conditions and disorders (e.g. distress, depressive, anxiety, and eating disorders) are more prevalent in people with diabetes (PWD) and associated with reduced quality of life and impaired glycaemic outcomes. Evidence supports a complex network between psychosocial factors and glycaemic control that can be highly variable between persons. It is assumed that subgroups exist that show different trajectories of glycaemia and mental health.\n\nBelonging to a particular subgroup may be linked with a higher risk of developing mental health problems compared to others. This suggests that it is possible to treat individuals in different subgroups in a manner that optimizes their treatment and can improve health outcomes. Accurate characterisation can inform more individualized care. This calls for a more personalised approach considering the idiosyncrasies of different subgroups.\n\nOver 3 years, the investigators have established the basis of a precision mental health approach for diabetes using n-of-1 analyses. By utilizing combined ecological momentary assessment (EMA: repeated daily sampling of psychosocial factors in everyday life) and continuous glucose monitoring (CGM), intensive longitudinal data per person could be collected. This enables the analysis of individual associations between glycaemic parameters and psychosocial variables and identification of individual sources of diabetes distress in each person.\n\nThe objective of the present study is to use of the n-of-1 approach to identify subgroups of PWD who share common characteristics in the associations between glucose and psychosocial variables. The identified subgroups shall be used to develop a digital twin for precision mental health in diabetes. The digital twin serves as representation of a real person, allowing to make simulations and predictions of the course of mental health and glycaemia. These predictions can inform diabetes care and lead to more precise, personalised treatment decisions.\n\nTo achieve this, a longitudinal panel including over 1,400 PWD who continuously complete EMA and questionnaire surveys and measure glucose levels using CGM was developed. Over 1000 clinical interviews to diagnose mental disorders have been conducted to identify major mental health conditions and map mental outcomes. To identify subgroups and develop the digital twin, the sampling will be expanded aiming at a total of 1,809 PWD. Incidence and remission of mental disorders will be determined via repeated interviews.\n\nThe complex networks between clinical, metabolic, and psychosocial data will be analysed using machine learning, leading to new insights with the potential to shape future guidelines. These results will be used by the digital twin to predict courses of glycaemic control and mental health, translating the individual evidence into direct treatment suggestions.",[131,132,133,134,135,136,101,137,102,138,139,140,141,142,143,144,145,146,147,148],"Diabetes (DM)","Diabete Mellitus","Diabete Type 1","Diabete Type 2","Diabetes Distress","Diabetes Complications","Depression Anxiety Disorder","Depression Disorders","Anxiety Disorder (Panic Disorder or GAD)","Anxiety Disorder NOS","Eating Disorder Binge","Anorexia Nervosa","Bulimia Nervosa","Eating Disorder Not Otherwise Specified","Depressed Mood","Anxiety Symptoms","Disordered Eating Behaviors","Fear of Hypoglycemia",[150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,135,124],"Digital Twin","Precision Medicine","Precision Mental Health","Subclassification","Trajectories","Subtypes","Person-reported Outcomes (PRO)","Ecological Momentary Assessment (EMA)","Continuous Glucose Monitoring (CGM)","People with Diabetes (PWD)","Diabetes Mellitus","HbA1c","Depression","Anxiety","Eating disorder","2025-11-27",{"date":167,"type":54},"2025-12-04",{"date":169,"type":54},"2025-01-01",{"date":171,"type":20},"2027-12-31",{"name":173,"class":88},"Forschungsinstitut der Diabetes Akademie Mergentheim",3,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":183,"conditions":184,"keywords":185,"overallStatus":197,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":62},"100607525","mental-health-mission-mood-disorder-cohort-study-100607525","NCT07189689","Mental Health Mission Mood Disorder Cohort Study","Inclusion Criteria:\n\n* Those aged 18 and above\n* Primary clinical diagnosis of MDD or bipolar disorder based on DSM-5\u002FICD-11 diagnostic criteria\n* Participant is willing and able to give informed consent for participation in the study\n* Possesses sufficient command of the English language required to complete study requirements, as assessed by the study team\n\nExclusion Criteria:\n\n* Inability to complete study activities as assessed by the study team\n* Presentation requires immediate emergency treatment\n* Presentation requires clinical input not available within the research clinic",{"count":182,"type":20},2000,"The current study aims to understand why some people with depression respond to treatment and others do not, using markers of clinical symptoms, both clinician reported outcome measures and patient reported outcome measures, demographic information, cognitive function, genetic sequence information (genomic), chemical measures of metabolism (metabolomic), protein makeup (proteomic) and the body's natural defence system (immune\u002Finflammatory markers) together with collections of cells that will facilitate new research to drive improvements in diagnosis and treatment of mood disorders that may be proving difficult to treat. This will allow future clinical trials within the NHS, academia and industry to drive forward new approaches and treatments.\n\nParticipants who provide consent for re-contact for future treatment trials and other research studies have the potential to benefit from this with participation in experimental studies and clinical trials associated with improved patient outcomes. Overall, the cohort will generally support greater access to research opportunities for a wider population of people.",[101,102,42],[186,187,162,188,189,190,191,192,193,194,195,196],"Observational","Cohort","UK","Mission","Bipolar","TRD","Difficult-to-treat","Treatment resistant depression","Bipolar depression","cohort study","Observational study","NOT_YET_RECRUITING","2025-09-29",{"date":200,"type":54},"2025-10-03",{"date":202,"type":20},"2025-10-01",{"date":204,"type":20},"2028-01-31",{"name":206,"class":88},"University of Oxford",{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":15,"minAge":213,"maxAge":214,"enrollmentInfo":215,"targetDuration":4,"studyType":74,"phases":216,"briefSummary":218,"conditions":219,"keywords":222,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":62},"100570360","phase-2-acceptability--safety-of-two-sequential-doses-of-psilocybin-in-bipolar-disorder-ii-depression-and-suicidality-100570360","NCT06706232","Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression and Suicidality","Inclusion Criteria:\n\n* Must have completed written informed consent\n* Must be at 25 years of age or older at screening (but below age of 70)\n* Confirmed Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of BD-II using clinical records and Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive disorder (OCD) and Related Neuropsychiatric Disorders (DIAMOND)\n* Must meet criteria for suicidality according to the INQ cutoff scores: A score of at least 12 on the Perceived Burden (PB) subscale and at least a score of 36 on the Thwarted Belongingness (TB) subscale indicating substantial risk for passive suicidal ideation\n* Must meet criteria for depression according to the MADRS cutoff scores: A score of 7-34 indicating mild to moderate depression\n* Must pass medical examination (physical exam, personal\u002Ffamily medical history, including consultation with current medical provider, ECG, about 4 tablespoons blood draw, psychiatric\u002Fpsychological assessments, urine drug test)\n* Willingness to taper down mood stabilizers and other relevant medications (including but not limited to: antidepressants, antipsychotics, lithium, benzodiazepines, Monoamine oxidase inhibitors (MAOIs), Selective serotonin reuptake inhibitors (SSRIs), Serotonin and norepinephrine reuptake inhibitors (SNRIs), A serotonin-norepinephrine-dopamine reuptake inhibitors (SNDRIs), Tricyclic antidepressants (TCAs), stimulants, cannabis, and other medications, supplements or therapeutics that affect serotonergic function) for the duration of the study before and during administration days (starting 5 weeks before administration), and be off medication for at least 2 weeks prior to administration\n* Willingness to stop allowed medication at least 24 h prior to administration of psilocybin as advised by study physician (e.g., benzodiazepines)\n* Ability to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits\n\nExclusion Criteria:\n\n* Participants who do not read\u002Fspeak English\n* Active suicidal ideation with at least some intent and\u002For plan (i.e., a current score of 4 or 5 on the C-SSRS)\n* History of medically significant suicide attempt in the last 6 months\n* Current or past history of Bipolar I disorder, psychotic symptoms or psychotic disorder, (including but not limited to schizophrenia, delusional disorder, schizoaffective disorder) clinically relevant personality disorder (such as borderline, antisocial, narcissistic or paranoid personality disorder), or any serious psychiatric comorbidity considered negatively impacting participation or safety (e.g., PTSD or severe substance use or alcohol disorder) assessed by medical history and\u002For a structured clinical interview\n* Have a first or second degree relative with Bipolar I disorder or a psychotic disorder\n* Currently experiencing a hypomanic or mixed-symptom episode\n* Have a psychiatric or other condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin\n* Any indication of a Personality Disorder (PD) such as but not limited to Borderline, Narcissistic, Antisocial, Paranoid, or Schizotypal PD based on Structured Clinical Interview for DSM-5 for PD and\u002For clinical judgment","25 Years","70 Years",{"count":5,"type":20},[217],"PHASE2","The purpose of the study is to assess the safety and acceptability of up to two sequential administrations of 25 mg psilocybin with additional therapeutic support in decreasing suicidality in patients with Bipolar Disorder (BD II) depression.",[220,44,221],"Bipolar II Disorder","Suicidality",[223,224],"Bipolar II Depression","Psilocybin","2025-07-15",{"date":227,"type":54},"2025-07-18",{"date":229,"type":54},"2025-07-07",{"date":231,"type":20},"2027-01",{"name":233,"class":88},"The University of Texas Health Science Center, Houston",{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":74,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":62},"100366908","phase-4-optimal-electrical-stimulus-during-electroconvulsive-therapy-100366908","NCT04057378","Optimal Electrical Stimulus During Electroconvulsive Therapy","Optimal Electrical Stimulus During Electroconvulsive Therapy for Depression: a National Register-based Randomized Trial","Inclusion Criteria:\n\n* At least 18 years old at the time of inclusion\n* Fulfilled diagnostic criteria for unipolar, or bipolar depressive episode according to ICD-10.\n* Has indication for and accepts ECT\n* Has a Swedish personal identity number\n* Capable of giving informed consent\n\nExclusion Criteria:\n\n• If the investigator judges a certain pulse width to be inappropriate for the patient.",{"count":242,"type":20},800,[76],"Synopsis\n\nAim: The purpose of the study is to determine the stimulus of electrical current during electroconvulsive therapy (ECT) that produces the optimal balance between antidepressant effect and memory disturbance. Specifically, this study aims to compare the 0.5 ms and 1.0 ms pulse width stimuli.\n\nDesign: National, register-based randomized trial, unmasked with two treatment arms.\n\nPrimary objective: To test the hypothesis that a 1.0 ms pulse width stimulus produces a higher remission rate (\\\u003C 11 on the MADRS-S) than a 0.5ms pulse width stimulus.\n\nSecondary objectives include testing for differences in:\n\nself-rated global health measured with the EQ5D-VAS subjective memory worsening (increase of 2 on the memory item of the CPRS) antidepressive response (decrease of 50% on the MADRS-S) number of ECTs in the treatment series readmission and suicide rate within 6 months Study population: patients with unipolar or bipolar depression. Sample size: 800 patients, 400 patients in each arm.\n\nInclusion criteria:\n\nAt least 18 years of age at the time of inclusion Diagnostic criteria fulfilled for unipolar, or bipolar depressive episode according to ICD-10.\n\nAn indication for and accepting ECT A Swedish personal identity number. Capable of giving informed consent.\n\nExclusion criteria:\n\nIf the investigator judges a certain pulse width to be inappropriate for the patient.\n\nInclusion time 2019-05-01-2022-11-15.\n\nAbbreviations\n\n1. CGI: Clinical Global Impression Scale\n2. CPRS: The Comprehensive Psychopathological Rating Scale\n3. ECT: Electroconvulsive therapy\n4. EQ5D: EuroQual-group 5 Dimensions Scale\n5. ICD-10: International Statistical Classification of Diseases and Related Health Problems. - 10th revision,\n6. MADRS-S: Montgomery-Åsberg Depression Rating Scale, self assessed version.\n7. Q-ECT: Swedish national quality register for ECT\n8. VAS: Visual analogue scale",[246,44],"Depressive Disorder, Major","2025-06-17",{"date":249,"type":54},"2025-06-22",{"date":251,"type":54},"2019-10-30",{"date":253,"type":20},"2027-11-15",{"name":117,"class":88},{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":71,"enrollmentInfo":262,"targetDuration":4,"studyType":74,"phases":264,"briefSummary":266,"conditions":267,"keywords":268,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":118},"100512937","bioclock-bright-light-therapy-for-depressive-disorders-100512937","NCT05958940","BioClock: Bright Light Therapy for Depressive Disorders","BioClock: Optimization, Working Mechanisms and Response Predictors of Bright Light Therapy for Depressive Disorders - a Multicentre Randomized Controlled Trial","Inclusion Criteria:\n\n* Age between 18 and 65.\n* Diagnosis of unipolar or bipolar depression (seasonal or non-seasonal) as assessed with the Mini-International Neuropsychiatric Interview (M.I.N.I.)\n* A current depressive episode (a score of 6 or higher on the Quick Inventory of depressive symptomatology Self Report (QIDS-SR)\n* Sufficient knowledge of Dutch or English language to fill in questionnaires\n* Provided Informed consent\n\nExclusion Criteria:\n\n* A current (hypo)manic or mixed episode (as assessed with the M.I.N.I.)\n* Current psychotic episode (as assessed with the M.I.N.I.)\n* Prominent active suicidality (score 10 or higher on the M.I.N.I. module)\n* Antidepressant therapy (medication, psychotherapy or BLT, or other forms of specific treatments for depression) that started less than 2 months prior to study entry\n* participants with bipolar disorder should be in mood-stabilizing treatment for at least 1 month in a recommended dosage,\n* Use of melatonin or agomelatine in the last month\n* Current use of antibiotics\n* Current use of light sensitivity increasing medication\n* Travelled across more than 1 time zone during past month or during the treatment\n* Travelled to sunny holiday locations\u002Fwinter sports during past month\n* pre-existing eye and skin disorders (retinitis pigmentosa, porphyria, chronic actinic dermatitis and sun-induced urticaria)\n* Systemic disorders with potential retinal involvement (rheumatoid arthritis and systemic lupus erythematosus)\n* Suffering from colour blindness (assessed by Ishihara colour plates)\n* Participated in night shift work in the last three months\n* (Retinal) blindness, severe cataract and glaucoma\n* Light-induced migraine or epilepsy\n* Pregnancy, or parents with a child younger than 18 months old",{"count":263,"type":20},231,[265],"NA","Bright Light Therapy (BLT) is a proven treatment for depression in seasonal and non-seasonal depressive disorders, as well as bipolar disorder. To make BLT more effective and practical in clinical settings and tailor it to individual needs, it is necessary to optimize the treatment approach, understand how the treatment works, and identify patient characteristics that predict response.\n\nThis clinical trial has three main goals:\n\n* Optimize the administration of BLT for patients with depressive episodes.\n* Gain a deeper understanding of the treatment mechanisms.\n* Determine which patients benefit the most from the treatment.\n\nThe specific objectives are as follows:\n\n* Investigate whether additional treatments and interventions related to lifestyle and the biological clock can enhance the effects of BLT.\n* Examine how BLT influences the body's internal clock and sleep quality, and how these factors contribute to the outcomes.\n* Identify patient characteristics and behaviours that can predict treatment outcomes.\n* Develop a brain model to better understand the impact of BLT on the brain.\n\nIn this study, patients will receive BLT with a light intensity of 10,000 lux for 30 minutes each morning over 5 consecutive days. The treatment duration will range from one to three weeks, depending on the improvement of depressive symptoms. Participants will be randomly assigned to one of three groups:\n\n* Home - Patients will receive BLT at home, following the standard guidelines for light therapy in the Netherlands.\n* LightCafé, fixed time: Patients will receive BLT in a café-like setting called the LightCafé, where the focus is not only on symptom improvement but also lifestyle enhancements and fostering social connections. The treatment time will be the same every day.\n* LightCafé, varying time: Patients will also receive BLT at the LightCafé, with treatment timing varying each day. Additionally, this group will wear glasses in the evening that filter blue light.\n\nThe study includes a baseline phase of up to two weeks, a treatment phase of up to three weeks, and a three-month follow-up phase. Patients will wear a motion watch to assess sleep-wake behaviour and physical activity during the day. Additionally, they will wear a broach that measures their personal light exposure throughout the day. Eight one-minute questionnaires per day will be sent to the participants' smartphones to assess vitality, sleep, and mood during the treatment. Predictors of treatment response, such as clinical characteristics, sleep measures, circadian parameters, and light-related behaviours, will be evaluated at baseline. In a small group of patients, salivary melatonin curves will be assessed before and after treatment. MRI scans will provide insights into functional and structural brain changes following light therapy treatment.",[40,44],[162,269,270,271,272,273,274,275,276,277],"Bright Light Therapy","Chronotherapy","Circadian Rhythm","Sleep","Life Style","Ecological Momentary Assessment","Actigraphy","Dim light melatonin onset","Response predictors","2025-01-07",{"date":280,"type":54},"2025-01-09",{"date":282,"type":54},"2024-02-08",{"date":284,"type":20},"2026-12",{"name":286,"class":88},"Universiteit Leiden",{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":15,"minAge":295,"maxAge":214,"enrollmentInfo":296,"targetDuration":4,"studyType":74,"phases":298,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":62},"100318280","phase-3-a-study-of-abilify-tabletaripiprazole-as-an-adjunctive-treatment-in-the-bipolar-depression-100318280","NCT03423680","A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression","A Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel Group, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Treatment of Major Depressive Episode Associated With Bipolar I or II Disorder","APOLLO","Inclusion Criteria:\n\n* Patients aged ≥ 19 and \\\u003C 70 years at the time of informed consent\n* Patients who are able to understand information required for providing a consent\n* Patients who have received a mood stabilizer (lithium or valproic acid)\n* Patients with bipolar I or II disorder accompanied by major depressive episode\n* Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 20 at both the screening and baseline visits\n\nExclusion Criteria:\n\n* Patients diagnosed with bipolar I or II disorder with mania, mixed or psychotropic features\n* Patients considered to have a high risk of suicide during the study period by the investigator based on current psychotic symptom and the patient's past medical history","19 Years",{"count":297,"type":20},390,[299],"PHASE3","This is an 8-week, multicenter, randomized, double blind, placebo controlled study to evaluate the efficacy and safety of aripiprazole as an adjunctive treatment with mood stabilizer for the treatment of patients (outpatients or inpatients) with type I or II bipolar disorder accompanied by major depressive episode, without any psychotropic features.\n\nThis study involves patients who are considered by the investigator not to have a proper improvement, despite receiving a mood stabilizer (lithium or valproic acid) for a sufficient (≥ 28 days) period of time during the current depressive episode.",[44],"2024-08-16",{"date":304,"type":54},"2024-08-19",{"date":306,"type":54},"2018-02-22",{"date":308,"type":20},"2025-12",{"name":310,"class":311},"Korea Otsuka Pharmaceutical Co., Ltd.","INDUSTRY",{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":214,"enrollmentInfo":320,"targetDuration":4,"studyType":74,"phases":322,"briefSummary":323,"conditions":324,"keywords":4,"overallStatus":197,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":4},"100524210","ketogenic-diet-for-depression-100524210","NCT06105762","Ketogenic Diet for Depression","KETO-MOOD: Ketogenic Diet for Microbiome Optimization and Overcoming Depression","KETO-MOOD","Inclusion criteria:\n\n* Unequivocal diagnosis of major depressive disorder or bipolar depression according to ICD-10 and ICD-11 (as soon as approved in Switzerland) criteria\n* Age ≥18 years\n* The patient can give informed consent as documented by signature\n* Interest in trying a dietary intervention\n* Participants must refrain from using any non-prescribed psychotropic agents during the study period including alcohol and illicit drugs such as cannabis; long term pain medication, caffeine and nicotine are excluded from that rule\n\nExclusion criteria:\n\n* Inability to follow the study procedures, e.g., because of a language barrier, neurological and interfering mental disorders, dementia\n* Anorexia nervosa\n* BMI \\\u003C18.5 kg\u002Fm2\n* Pregnancy or breast feeding\n* Current electroconvulsive therapy (ECT)\n* Concurrent ketamine therapy\n* Inability to follow the procedures of the study, e.g. due to language barrier, neurological and interfering mental disorders, high-grade dementia, etc.\n* Porphyria\n* Type 1 diabetes\n* Insulin-dependent type 2 diabetes\n* Contraindicated medical conditions; besides rare hereditary metabolic disorders (typically diagnosed in childhood), contraindications comprise acute pancreatitis, nephrolithiasis, advanced renal failure, advanced liver failure, advanced congestive heart failure, advanced pulmonary disease with respiratory failure, and concurrent use of SGLT2 inhibitors",{"count":321,"type":20},120,[265],"Globally, it's estimated that around 300 million people are affected by depressive illness, and even with access to modern mental health care, long-term recovery is uncommon. Recently, there has been increasing interest in a promising intervention: the ketogenic diet. This diet restricts carbohydrate intake, promoting the breakdown of fats into circulating ketone bodies, which can act as an additional energy source for the brain, potentially reducing its reliance on glucose. While various sources of evidence suggest the potential benefits of the ketogenic diet for individuals with depression, robust clinical studies on its efficacy in depressed patients are lacking. Our goal is to conduct an eight-week, assessor-blinded, randomized controlled trial to investigate the therapeutic effects of a very low-carbohydrate, high-fat ketogenic diet compared to an active comparator diet in individuals with depression.",[325,43,44],"Depressive Disorder","2023-10-23",{"date":328,"type":54},"2023-10-30",{"date":330,"type":20},"2024-01-01",{"date":332,"type":20},"2027-07-01",{"name":334,"class":335},"University Psychiatric Clinics Basel","NETWORK"]