EEG Microstate Parameters and Neuroinflammatory Biomarkers in Patients With Treatment-Resistant Major Depressive Disorder Receiving ECT
Recruiting · NCT07748091 · Observational (researchers observe without assigning treatment) · Lead sponsor: Istanbul University - Cerrahpasa
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- İstanbul University- Cerrahpasa, Cerrahpasa Medicine Faculty, Psychiatry Department - Istanbul, Bakırköy, Turkey (Türkiye)