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NCT07740694Toboroz

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 31.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Toboroz
Vizsgálattípus
Megfigyeléses
Résztvevők száma
62 (tervezett)
Első benyújtás
2026. júl. 5.
Kezdés
2025. dec. 1.
Elsődleges befejezés
2026. dec.
Fő szponzor
Istanbul University - Cerrahpasa
NCT-szám
NCT07740694

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Tervezett résztvevők: 62
  • 2025. dec. 1. és az elsődleges befejezés (2026. dec.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • Myocardial infarction within the previous 3 months.
  • Cerebrovascular disease within the previous month.
  • Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the previous month.
  • 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.

Más betegség

  • Primary neurological disorders (e.g., dementia or traumatic brain injury).
  • Schizophrenia or other psychotic disorders.
  • Cognitive impairment severe enough to prevent adequate cooperation during EEG recording.
  • Current alcohol or substance use disorder.
  • Active infectious disease.

Egyéb

  • Intracranial space-occupying lesions.
  • Increased intracranial pressure.
  • Unstable cerebral aneurysm.
  • Pheochromocytoma.

Kiket keres a vizsgálat

  • 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.

Életkor a regiszterben: 55 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
İstanbul University- Cerrahpasa, Cerrahpasa Medicine Faculty, Psychiatry DepartmentIstanbulTörökországToboroz

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