[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bipolar-depression-depressed-phase\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bipolar-depression-depressed-phase":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,58,88],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":36,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100649721","eeg-microstate-and-neuroinflammatory-biomarkers-in-older-age-patients-with-major-depressive-disorder-receiving-ect-100649721",false,"NCT07740694","EEG Microstate and Neuroinflammatory Biomarkers in Older Age Patients With Major Depressive Disorder Receiving ECT","The Relationship Between EEG Microstate Parameters, Neuroinflammatory Biomarkers and Treatment Response in Older Patients With Major Depressive Disorder or Bipolar Disorder Undergoing Electroconvulsive Therapy","Inclusion Criteria:\n\nPatient Group\n\n* Age ≥55 years.\n* Diagnosis of Major Depressive Disorder or Bipolar Disorder, current major depressive episode, according to DSM-5 criteria.\n* Clinical indication for electroconvulsive therapy (ECT).\n* Ability to provide written informed consent.\n* Willingness to participate in the study.\n\nHealthy Control Group:\n\n* Age ≥55 years.\n* No current psychiatric disorder.\n* No known neurological disorder.\n* Good general physical health.\n* No current use of medications known to affect EEG activity or inflammatory biomarkers significantly.\n* Ability to provide written informed consent.\n* Willingness to participate in the study.\n\nExclusion Criteria:\n\n* Primary neurological disorders (e.g., dementia or traumatic brain injury).\n* Schizophrenia or other psychotic disorders.\n* Intracranial space-occupying lesions.\n* Increased intracranial pressure.\n* Myocardial infarction within the previous 3 months.\n* Cerebrovascular disease within the previous month.\n* Unstable cerebral aneurysm.\n* Pheochromocytoma.\n* Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the previous month.\n* Cognitive impairment severe enough to prevent adequate cooperation during EEG recording.\n* Current alcohol or substance use disorder.\n* Active infectious disease.\n* Uncontrolled autoimmune or chronic inflammatory disorders. Participants with stable disease who had received the same maintenance treatment within the previous 3 months were eligible for inclusion.",true,"ALL","55 Years",{"count":20,"type":21},62,"ESTIMATED","OBSERVATIONAL","This study aims to investigate the neurophysiological and inflammatory changes associated with electroconvulsive therapy (ECT) in older age patients diagnosed with Major Depressive Episode, Major Depression, and Bipolar Disorder, using microstate analysis derived from resting-state electroencephalography (EEG) recordings. Within this scope, EEG recordings obtained before and after ECT will be compared to determine the relationships between changes in microstate parameters and inflammatory marker levels, clinical variables, and psychometric scale scores reflecting clinical improvement. Peripheral blood samples collected from the same patient group will be analyzed for complete blood count parameters as well as levels of interleukin-1 alpha (IL-1α), interleukin-1 beta (IL-1β), interleukin-2 (IL-2), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), tumor necrosis factor-alpha (TNF-α), soluble glycoprotein 130 (sgp-130), soluble interleukin-6 receptor (sIL-6R), interferon gamma-induced protein 10 kDa (IP-10), and C-reactive protein (CRP). In addition, inflammatory indices, including the Neutrophil-to-Lymphocyte Ratio (NLR), Platelet-to-Lymphocyte Ratio (PLR), and Monocyte-to-Lymphocyte Ratio (MLR), will be calculated. The association between baseline levels of these biomarkers and treatment response will be evaluated. Moreover, changes in biomarker levels following ECT will be statistically examined in relation to clinical scale scores and EEG microstate parameters. Although microstate analysis and inflammatory biomarkers have each been extensively investigated in psychiatric disorders, studies evaluating these two biomarkers together, particularly with the inclusion of healthy control participants, in the older age population remain limited. In this regard, the present study aims to evaluate the effects of ECT on older age patients using objective neurophysiological indicators, contribute to the understanding of the pathophysiology of depression at the level of brain networks, and provide a scientific basis for the development of personalised treatment approaches in the future.",[25,26,27,28,29,30,31,32,33,34,35],"Major Depression Moderate","Major Depression Severe","Major Depression With Comorbid Anxiety Symptoms","Major Depression With Panic Attacks","Major Depression With Psychotic Features","Major Depressive Episode","Bipolar Affective Disorder","Bipolar Depression Depressed Phase","Bipolar Depression","Bipolar Anhedonic Depression","Catatonia",[37,30,38,39,40,41,42,43,33,44],"ECT","Major Depression","Inflammatory biomarker","EEG","Microstate","Treatment Resistant Depression","Difficult to Treat Depression","Bipolar Disorder","RECRUITING","2026-07-28",{"date":48,"type":49},"2026-07-31","ACTUAL",{"date":51,"type":49},"2025-12-01",{"date":53,"type":21},"2027-02",{"name":55,"class":56},"Istanbul University - Cerrahpasa","OTHER",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":17,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":84,"leadSponsor":86,"locationsCount":57},"100645790","phase-4-the-effects-of-lumateperone-on-obesity-and-physiologic-aging-and-their-association-with-antidepressant-response-in-bipolar-depression-100645790","NCT07699445","The Effects of Lumateperone on Obesity and Physiologic Aging and Their Association With Antidepressant Response in Bipolar Depression","The Effects of Lumateperone on Obesity and Physiologic Aging and Their Correlation With Antidepressant Response in Bipolar Depression","Inclusion Criteria:\n\n1. Aged 18 to 65 years.\n2. Meets DSM-V criteria for Bipolar I Disorder -Depressed without psychosis as confirmed by a semi-structured clinical interview that includes the Mini International Neuropsychiatric Interview.\n3. Current episode at least 4 weeks in duration but not longer than 12 months.\n4. Depression score \\> 20 on the Montgomery Asberg Depression Rating Scale (MADRS).\n5. BMI \\> 30\n6. Capable of providing informed consent.\n\nExclusion Criteria:\n\n1. Meets DSM-V criteria for Schizophrenia, Schizoaffective disorder, or has significant mood-incongruent psychotic symptoms.\n2. Young Mania Rating Scale score \\>12.\n3. Meets DSM-V criteria for rapid cycling.\n4. Co-Morbid psychiatric illness, other than generalized anxiety and specific phobias, that in the opinion of the investigator is severe enough that it would likely interfere with the interpretation of changes in the subject's mood state.\n5. Meets DSM-V criteria for an active substance use disorder within the past month.\n6. Active medical condition that in the opinion of the investigator would contribute to the subject's depressed mood (e.g. hypothyroidism).\n7. Significant risk of suicide or self -harm as assessed by clinical interview and the Columbia Suicide Severity Rating Scale (C-SSRS).\n8. Significant risk of harm to others as assessed by clinical interview.\n9. Pregnancy, or, in women of child-bearing potential, an unwillingness to use an accepted method of birth control for the duration of the study.\n10. Current or prior treatment with lumateperone.\n11. Moderate or severe hepatic impairment.\n12. Current treatment with strong or moderate CYP3A4 inhibitors or CYP3A4 inducers.\n13. History of seizure disorder.\n14. Significant cardiovascular or cerebrovascular disease that, in the opinion of the investigator, would increase study risk.\n15. Dementia-related psychosis.\n16. Known hypersensitivity or allergy to lumateperone or any of its components.","18 Years","65 Years",{"count":68,"type":21},25,"INTERVENTIONAL",[71],"PHASE4","This research study examines how a medication called lumateperone may affect mood symptoms, and inflammation in adults with bipolar disorder over approximately 6 weeks. An MRI scan to calculate biological age of the brain will also be obtained at the start of the study.",[32,74],"Obesity & Overweight",[76,77,78],"Bipolar disorder","Depression","obesity","NOT_YET_RECRUITING","2026-07-07",{"date":82,"type":49},"2026-07-13",{"date":48,"type":21},{"date":85,"type":21},"2028-07-31",{"name":87,"class":56},"Massachusetts General Hospital",{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":65,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":69,"phases":97,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100591902","phase-3-low-frequency-right-dorsolateral-pre-frontal-cortical-repetitive-tms-for-bipolar-depression-100591902","NCT06986460","Low Frequency Right Dorsolateral Pre Frontal Cortical Repetitive TMS for Bipolar Depression","FLARE","Inclusion Criteria:\n\n1. Must be deemed to have capacity to provide informed consent;\n2. Must be an outpatient;\n3. Have a DSM 5 diagnosis of bipolar disorder (type I or II), current episode depressed confirmed by Mini-International Neuropsychiatric Interview version 7.0.2 (MINI) assessed during TRIBE trial participation with no contradictory evidence that the current episode is depressed from FLARE trial screening assessments (YMRS\\>10\u002FPHQ-9 \\\u003C10);\n4. older than 18 years;\n5. failure to achieve a clinical response within the TRIBE study (CTO#: 4343) defined as ≤50% response from baseline to 6 weeks on the HRSD-17.\n6. Score ≥10 on PHQ-9 at both (i) the 6 weeks follow-up in the TRIBE trial and (ii) at screening;\n7. ≤3 months from completion of the TRIBE study;\n8. not currently experiencing a mixed or manic episode (YMRS ≤10);\n9. no increase or initiation of psychotropic medication with intention of treating depressive symptoms in the 4 weeks prior to screening. This excludes targeted treatment of insomnia with trazodone, melatonin, low-dose doxepin \\[3-6mg\\], low-dose benzodiazepines \\[≤2mg lorazepam daily equivalent\\], non-benzodiazepine benzodiazepine receptor agonists, or orexin antagonists;\n10. currently receiving treatment with one of the following non-anticonvulsant mood stabilizer with evidence for prevention of mania: lithium, quetiapine, asenapine, aripiprazole, paliperidone (\\>6mg), risperidone, olanzapine, ziprasidone, haloperidol, clozapine (lurasidone and cariprazine are excluded due to lack of evidence for preventing mania);\n11. able to adhere to the treatment schedule;\n12. pass the TMS adult safety screening questionnaire.\n\nExclusion Criteria:\n\n1. have a history of MINI diagnosis of a substance use disorder (other than nicotine and\u002For caffeine) within the last 3 months;\n2. have a concomitant major unstable medical illness;\n3. have active suicidal intent;\n4. are pregnant or intend to get pregnant during the study;\n5. have a lifetime MINI diagnosis of schizophrenia or schizoaffective disorder;\n6. have psychotic symptoms within the current episode;\n7. have a MINI anxiety disorder, trauma-related disorder, obsessive compulsive disorder, or personality disorder assessed by a study investigator to be primary and\u002For causing greater impairment than BD-DE;\n8. failure of an adequate acute course of ECT as defined by ATHF-SF during the current episode;\n9. have any clinically significant neurological disorder (e.g., recent major cerebrovascular accident), or any history of seizure except those therapeutically induced by ECT or with clear precipitant (e.g., febrile seizure of childhood, alcohol withdrawal, etc.);\n10. have any intracranial implant (e.g., aneurysm clips, shunts, stimulators,) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;\n11. if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study;\n12. have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;\n13. are currently taking lorazepam ≥2 mg daily (or equivalent) due to the potential to limit rTMS efficacy;\n14. are currently taking, any dose of an anticonvulsant due to the potential to limit rTMS efficacy;\n15. if anticonvulsants have been discontinued prior to screening, at least 5 half-lives have elapsed until screening to allow sufficient drug clearance;\n16. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).\n17. participant was withdrawn from the TRIBE study due to safety concerns or at the discretion of the PI.\n18. any history of substance use in the last 4 weeks which poses a safety concern to undergo rTMS as assessed by the PI's review of responses to the trial's 'Substance Use Screening Questions Form'.",{"count":96,"type":21},80,[98],"PHASE3","The purpose of this trial is to conduct an adequately powered clinical trial of once daily LFR for individuals diagnosed with treatment-resistant BD-DE who have not responded to iTBS or sham treatment applied to the left DLPFC. This work will develop the evidence supporting the use of LFR rTMS for individuals with treatment-resistant BD-DE who currently have limited treatment options to alleviate their suffering. Participants will come for 30 days of LFR, with a 6-week follow-up period. Symptoms of depression (for determining treatment efficacy) and mania (for determining treatment safety) will be assessed using the 17-item Hamilton Rating Scale for Depression (HRSD-17) and the Young Mania Rating Scale (YMRS) every five treatments during the treatment course, and at 1 week and 6 week after treatment completion.",[32],[102,33,103,104],"rTMS","treatment-resistant","LFR","2026-03-16",{"date":107,"type":49},"2026-03-18",{"date":109,"type":49},"2025-05-27",{"date":111,"type":21},"2030-05",{"name":113,"class":56},"Tyler Kaster",2]