EEG Microstate and Neuroinflammatory Biomarkers in Older Age Patients With Major Depressive Disorder Receiving ECT

Recruiting now

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, Bipolar Affective Disorder, Bipolar Depression Depressed Phase, Bipolar Depression, Bipolar Anhedonic Depression, Catatonia

In brief

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.

Key facts

Study ID

NCT07740694

Run by

Istanbul University - Cerrahpasa

People needed

62

Starts

2025-12-01

Expected to finish

2027-02-01

Last updated by the study team

2026-07-31

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patient Group
• Age ≥55 years.
• Diagnosis of Major Depressive Disorder or Bipolar 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.

You may not qualify if…

• Primary neurological disorders (e.g., dementia or traumatic brain injury).
• Schizophrenia or other psychotic disorders.
• 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.
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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