[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"major-depression-moderate\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:major-depression-moderate":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,55,80,113],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100650371","eeg-microstate-parameters-and-neuroinflammatory-biomarkers-in-patients-with-treatment-resistant-major-depressive-disorder-receiving-ect-100650371",false,"NCT07748091","EEG Microstate Parameters and Neuroinflammatory Biomarkers in Patients With Treatment-Resistant Major Depressive Disorder Receiving ECT","The Relationship of EEG Microstate Parameters and Neuroinflammatory Biomarkers With Treatment Response in Patients With Treatment-Resistant Major Depressive Disorder Receiving Electroconvulsive Therapy","Inclusion Criteria:\n\nPatient Group\n\n* Age 18-60 years\n* Diagnosis of Major Depressive 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* Bipolar disorder diagnosis,\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* Autoimmune or chronic inflammatory disorders.\n* Current use of systemic corticosteroids, immunosuppressive agents, or other medications known to affect inflammatory biomarkers significantly.",true,"ALL","18 Years","60 Years",{"count":21,"type":22},62,"ESTIMATED","2 Months","OBSERVATIONAL","This study aims to investigate the neurophysiological and inflammatory changes associated with electroconvulsive therapy (ECT) in patients diagnosed with Major Depressive Disorder who are resistant to at least two antidepressant treatments, 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.\n\nPeripheral 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.\n\nAlthough 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, remain limited. In this regard, the present study aims to evaluate the effects of ECT on patients with treatment-resistant depression using objective neurophysiological indicators, to contribute to the understanding of the pathophysiology of depression at the level of brain networks, and to provide a scientific basis for the development of personalized treatment approaches in the future.",[27,28,29,30,31,32,33,34],"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","Major Depressive Disorder (MDD","Major Depression",[36,37,38,39,40,41,34,32],"ECT","EEG","Treatment Resistant Depression","Difficult to Treat Depression","Microstate","Inflammatory biomarker","RECRUITING","2026-07-31",{"date":45,"type":46},"2026-08-05","ACTUAL",{"date":48,"type":46},"2026-01-01",{"date":50,"type":22},"2027-03",{"name":52,"class":53},"Istanbul University - Cerrahpasa","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":16,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":64,"conditions":65,"keywords":71,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":54},"100649721","eeg-microstate-and-neuroinflammatory-biomarkers-in-older-age-patients-with-major-depressive-disorder-receiving-ect-100649721","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.","55 Years",{"count":21,"type":22},"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.",[27,28,29,30,31,32,66,67,68,69,70],"Bipolar Affective Disorder","Bipolar Depression Depressed Phase","Bipolar Depression","Bipolar Anhedonic Depression","Catatonia",[36,32,34,41,37,40,38,39,68,72],"Bipolar Disorder","2026-07-28",{"date":43,"type":46},{"date":76,"type":46},"2025-12-01",{"date":78,"type":22},"2027-02",{"name":52,"class":53},{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":96,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":54},"100631616","phase-1-shortened-lsd-intervention-for-major-depressive-disorder-100631616","NCT07503002","Shortened LSD Intervention for Major Depressive Disorder","SLIM","Inclusion Criteria:\n\n* Have given written informed consent\n* Meet DSM-5 criteria for MDD\n* MADRS \\>= 28 at screening Can read, write, and speak English fluently\n* Be judged by study team clinicians to be at low risk for suicidality\n\nExclusion Criteria:\n\n* Women who are pregnant, nursing, or not practicing an effective means of birth control\n* Cardiovascular conditions: hypertension with resting blood pressure systolic \\>139 or diastolic \\>89, angina, heart rate \\> 99, a clinically significant ECG abnormality (e.g., atrial fibrillation, QTc \\> 450), TIA in the last 6 months stroke, peripheral or pulmonary vascular disease, cardiac valvulopathy\n* Epilepsy\n* Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia\n* Currently taking antipsychotics, or MAO inhibitors\n* Patients taking antidepressant medications and unable to taper\n* Moderate or strong CYP2D6 inhibitor antidepressants must undergo a washout period of 4 weeks or five half-lives prior to treatment\n* Currently taking CYP2D6 inhibitor other than an antidepressant that will be tapered\n* Currently taking efavirenz, Acetaldehyde dehydrogenase inhibitors such as disulfiram (Antabuse), Alcohol dehydrogenase inhibitors, or UGT1A9 inhibitors or UGT1A10 inhibitors such as phenytoin, regorafenib, eltrombopag\n* Have a seizure disorder, multiple sclerosis, history of significant head trauma, CNS tumor, movement disorders or any neurodegenerative condition\n* Morbidly obese (\\>100 lbs. above ideal body weight, or BMI \\>=40, or BMI \\>=35 with high blood pressure or diabetes)\n* Be judged by a study team clinician to be at risk for moderate or severe alcohol or benzodiazepine withdrawal\n* Body weight \\\u003C 45 kg\n* Significant acute adverse reaction (e.g., dystonia) to an antipsychotic\n* Current or past history of meeting DSM-5 criteria for Schizophrenia, Psychotic Disorder (including substance-induced), Bipolar I or II Disorder or Major\n* Depression with psychotic features\n* Have a first degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or Bipolar I Disorder.","21 Years","70 Years",{"count":90,"type":22},10,"INTERVENTIONAL",[93],"PHASE1","The purpose of this study is to determine the safety and clinical effectiveness of a shortened lysergic acid diethylamide (LSD) experience. This will be achieved by administering the drug risperidone 45-minutes after the administration of LSD.",[27,28,34],[97,98,99,100,101,102],"LSD","lysergic acid diethylamide","depression","MDD","major depression","major depressive","NOT_YET_RECRUITING","2026-07-23",{"date":106,"type":46},"2026-07-24",{"date":108,"type":22},"2026-08-31",{"date":110,"type":22},"2027-12-01",{"name":112,"class":53},"Johns Hopkins University",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":91,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":54},"100603750","rtms-for-youth-inpatients-with-depression-100603750","NCT07140575","rTMS for Youth Inpatients With Depression","Seamless Integration of Repetitive Transcranial Magnetic Stimulation (rTMS) for Youth Inpatients With Depression: A Feasibility Study","Inclusion Criteria:\n\n* age 14-19 years\n* primary diagnosis of major depressive disorder or of bipolar I or II disorder, current episode depressed with no psychotic or mixed features\n* current episode of depression lasting at least 4 weeks\n* failed ≥1 evidence-based psychotherapy or antidepressant\n* have a GRID-HAMD-17 (17-item Hamilton Depression Rating Scale) score of ≥16 (moderate-severe range)\n* currently an inpatient or suitable for an elective inpatient admission\n\nExclusion Criteria:\n\n* lifetime diagnosis of a psychotic disorder, anorexia nervosa, bulimia nervosa diagnosis of a substance use disorder (except caffeine and tobacco) within the past year\n* obsessive compulsive disorder or personality disorder that is the main source and driver of distress\n* active psychosis and\u002For mania\n* history of epilepsy or any other neurologic condition that includes a history of seizures\n* use of medications that lower the seizure threshold\n* pregnancy or nursing\n* history of severe headaches within the previous year\n* improvement in depressive symptom severity between screening and baseline by 25% or more\n* inability to adhere to the protocol","14 Years","19 Years",{"count":123,"type":22},30,[125],"NA","Youth aged 15-24 are likelier to have depression than all age groups in Canada. One-third of depressed youth do not respond to psychotherapy and\u002For antidepressant medications. A treatment called repetitive transcranial magnetic stimulation or rTMS has proven helpful in adolescents and young adults whose depressive symptoms have been difficult to treat with psychotherapy and\u002For antidepressants. Unfortunately, youth find rTMS difficult to access because it is not funded by the Ontario Health Insurance Plan, is typically only offered to adults, and the treatment schedule usually involves once-daily sessions, 5 days\u002Fweek, for 4-6 weeks, which is associated with travel and opportunity costs e.g. missing school. This project looks at the feasibility of a new treatment pathway that allows youth with difficult-to-treat depression in hospital to receive rTMS twice-daily while engaging in on-unit schooling and therapeutic support. This \"accelerated\" way of providing rTMS is safe, has equal effectiveness to once-daily rTMS, and can shorten the time needed for treatment. This pathway is for youth already staying in hospital for difficult-to-treat depression or youth outside hospital who have difficult-to-treat depression that interferes with daily function to such a degree that they would benefit from staying in hospital. The investigators anticipate integrating rTMS and inpatient care for youth will be feasible, that it will be acceptable and accessible to youth and families, and there will be sufficient demand for this new treatment pathway. If successful, this project will inform care for youth with difficult-to-treat depression in Ontario and beyond.",[27,128],"Feasibility Studies",[130,131,132,133,134,135,136,137,138],"feasibility study","major depressive disorder","adolescent","youth","repetitive transcranial magnetic stimulation","neuromodulation","rTMS","accelerated","inpatient","2025-08-18",{"date":141,"type":46},"2025-08-24",{"date":143,"type":22},"2025-08",{"date":145,"type":22},"2027-12",{"name":147,"class":53},"Sunnybrook Health Sciences Centre"]