Recruiting

EEG Microstate Parameters and Neuroinflammatory Biomarkers in Patients With Treatment-Resistant Major Depressive Disorder Receiving ECT

ClinicalTrials.gov IDNCT07748091

PhaseNot Applicable

Enrollment62

SponsorIstanbul University - Cerrahpasa

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

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. 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, 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.

Interventions

Device: Electroconvulsive Therapy — ECT will be administered using the Thymatron System IV Integrated ECT Device under general anesthesia, in accordance with standard clinical protocols. Treatments will be delivered using bilateral electrode placement with brief-pulse square-wave stimulation, and if side effects are seen, right unilateral electrode placement will be applied. The duration of treatment, number of sessions, and stimulation parameters will be determined according to each patient's clinical condition.

Primary outcomes

Clinical Response and Remission Assessed by the Montgomery-Åsberg Depression Rating Scale (These assessments will be repeated within 1 week before ECT starts and at 14+6 days and 8 weeks + 6 days after ECT cessation.)
Clinical Response Assessed by Hamilton Depression Rating Scale (These assessments will be repeated within 1 week before ECT starts and at 14+6 days and 8 weeks + 6 days after ECT cessation.)
EEG Microstate Duration (These assessments will be repeated within 1 week before ECT starts and 14+6 days and 8 weeks + 6 days after ECT cessation.)
EEG Microstate Occurrence (These assessments will be repeated within 1 week before ECT starts and 14+6 days and 8 weeks + 6 days after ECT cessation.)
EEG Microstate Coverage (These assessments will be repeated within 1 week before ECT starts and 14+6 days and 8 weeks + 6 days after ECT cessation.)
EEG Microstate Transition Probability (These assessments will be repeated within 1 week before ECT starts and 14+6 days and 8 weeks + 6 days after ECT cessation.)

Eligibility information

Inclusion Criteria: Patient Group * Age 18-60 years * Diagnosis of Major Depressive Disorder, current major depressive episode, according to DSM-5 criteria. * Clinical indication for electroconvulsive therapy (ECT). * Ability to provide written informed consent. * Willingness to participate in the study. Healthy Control Group: * Age ≥55 years. * No current psychiatric disorder. * No known neurological disorder. * Good general physical health. * No current use of medications known to affect EEG activity or inflammatory biomarkers significantly. * Ability to provide written informed consent. * Willingness to participate in the study. Exclusion Criteria: * Primary neurological disorders (e.g., dementia or traumatic brain injury). * Schizophrenia or other psychotic disorders. * Bipolar disorder diagnosis, * Intracranial space-occupying lesions. * Increased intracranial pressure. * Myocardial infarction within the previous 3 months. * Cerebrovascular disease within the previous month. * Unstable cerebral aneurysm. * Pheochromocytoma. * Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the previous month. * Cognitive impairment severe enough to prevent adequate cooperation during EEG recording. * Current alcohol or substance use disorder. * Active infectious disease. * Autoimmune or chronic inflammatory disorders. * Current use of systemic corticosteroids, immunosuppressive agents, or other medications known to affect inflammatory biomarkers significantly.

Study locations

İstanbul University- Cerrahpasa, Cerrahpasa Medicine Faculty, Psychiatry Department, Istanbul, Bakırköy Turkey (Türkiye)

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.