An observational study in Major Depression Moderate, Major Depression Severe and Major Depression With Comorbid Anxiety Symptoms, sponsored by Istanbul University - Cerrahpasa. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Istanbul University - Cerrahpasa · Observational
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.
Major Depressive Disorder (MDD) and Major Depressive Episodes are leading causes of disability worldwide because of the substantial functional impairment they cause in affected individuals as well as their considerable socioeconomic burden. Late-life depression is associated with physical disability, worsening of coexisting medical illnesses, institutionalization, and increased mortality. The primary goals of treatment are to achieve complete remission, restore psychosocial functioning and quality of life, and prevent relapse and recurrence. All patients diagnosed with depression should receive appropriate psychoeducation, followed by antidepressant pharmacotherapy and/or psychotherapy through a shared decision-making process involving both the clinician and the patient.
Electroconvulsive therapy (ECT) is currently regarded as one of the most effective treatment modalities for Major Depressive Episode. Among elderly patients with severe major depressive episode, with or without psychotic features, particularly those presenting with active suicidal ideation, inadequate response to pharmacotherapy and/or psychotherapy, or intolerance to pharmacological treatment, ECT provides rapid clinical improvement with remission rates approaching 80%, making it one of the most effective biological treatment options currently available. Despite its well-established clinical efficacy, the mechanisms underlying ECT's therapeutic effects remain incompletely elucidated, and several biological, neurochemical, and structural hypotheses have been proposed.
Electroencephalography (EEG) is a non-invasive neurophysiological technique that measures fluctuations in the electrical activity generated by neuronal populations with excellent temporal resolution. Brief periods of stable scalp topographies lasting approximately 80-120 milliseconds are referred to as EEG microstates. These microstates are considered the electrophysiological correlates of transient large-scale functional brain networks. Parameters such as microstate duration, frequency of occurrence, coverage, and transition probability provide valuable information about the brain's functional organization and dynamic stability.
Although EEG-based studies investigating the effects of ECT on neuroplasticity, neurotransmitter systems, hippocampal volume, functional connectivity, and electrophysiological dynamics have attracted increasing attention in recent years, studies specifically focusing on EEG microstate analysis remain limited, especially in the older age population. Existing investigations are generally characterized by relatively small sample sizes, heterogeneity in treatment protocols, and methodological differences that may influence microstate measurements, emphasizing the need for larger and better-controlled studies.
As the search for reliable predictors of treatment response has intensified, increasing evidence suggests that abnormalities in immune regulation contribute to the pathophysiology of both unipolar and bipolar depression, highlighting the immune system as a promising source of biological markers. In particular, accumulating evidence indicates that pro-inflammatory cytokines, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and C-reactive protein (CRP), as well as anti-inflammatory cytokines such as interleukin-2 (IL-2) and interleukin-10 (IL-10), are involved in the pathophysiology of depression and may influence response to antidepressant treatment and electroconvulsive therapy (8-10). Furthermore, a recent meta-analysis demonstrated significantly higher neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) values in patients with depression compared with healthy controls. However, studies evaluating NLR, PLR, and monocyte-to-lymphocyte ratio (MLR) as predictors of response to ECT remain scarce.
Accordingly, the present study aims to investigate the neurophysiological changes associated with ECT in elderly patients diagnosed with Major Depressive Disorder through resting-state EEG microstate analysis. EEG recordings obtained before and after ECT will be compared to determine whether significant changes occur in microstate parameters, including duration, frequency, coverage, and transition probability. Furthermore, the relationships between changes in EEG microstate parameters and psychometric measures reflecting clinical improvement will be evaluated.
In addition, peripheral blood samples obtained from the same patient cohort will be analyzed to determine complete blood count parameters together with concentrations 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 (sgp130), soluble interleukin-6 receptor (sIL-6R), C-reactive protein (CRP), and inflammatory indices including NLR, PLR, and MLR. Baseline inflammatory biomarker levels will be evaluated as potential predictors of treatment response, while post-treatment changes will be examined in relation to both clinical outcomes and EEG microstate parameters. By investigating the interactions between neurophysiological and inflammatory biomarkers, this study aims to identify objective predictors of ECT response and contribute to the development of more personalized treatment strategies for late-life depression.
This prospective observational study will be conducted at the Department of Psychiatry, Cerrahpaşa Faculty of Medicine, Istanbul University-Cerrahpaşa. Patients aged 55 years or older who meet the DSM-5 diagnostic criteria for Major Depressive Disorder and Bipolar Disorder Major Depressive Episode, have been clinically indicated for electroconvulsive therapy (ECT), and voluntarily agree to participate in the study will be enrolled after providing written informed consent.
Resting-state EEG recordings will be obtained at three time points: within 1 week before the initiation of ECT, 2 weeks after completion of the ECT course, and 2 months after completion of treatment.
EEG recordings will be acquired using a computerized 19-channel EEG system equipped with Ag-AgCl disc electrodes positioned according to the International 10-20 System. The average of the A1 and A2 earlobe electrodes will serve as the reference. Signals will be sampled at 512 Hz with a high-pass filter of 0.30 Hz, a low-pass filter of 70 Hz, and an additional 50-Hz notch filter.
Each recording session will last 10 minutes under resting-state conditions, consisting of 5 minutes with eyes open followed by 5 minutes with eyes closed. Participants will be instructed to remain awake, relaxed, motionless, and silent throughout the recording. Raw EEG data will undergo standard preprocessing procedures, including artifact rejection, band-pass filtering, and re-referencing before subsequent analyses.
EEG microstate analysis will be performed using MICROSTATELAB v2.1, an EEGLAB extension implemented in MATLAB. Four canonical EEG microstate classes (A, B, C, and D) will be identified for each participant.
The following microstate parameters will be calculated:
Duration: the mean duration (milliseconds) during which an individual microstate remains stable after onset, reflecting the temporal stability of the underlying neural network.
Frequency (Occurrence): the average number of occurrences of each microstate per second (Hz), representing the activation tendency of the corresponding functional network.
Coverage: the percentage of the total recording time occupied by each microstate, reflecting its relative contribution to overall brain activity.
Transition Probability (TP): the probability of transitions between different microstate classes. For example, the transition probability from microstate A to microstate B is calculated as the proportion of A-to-B transitions relative to all transitions originating from microstate A. This parameter provides information regarding the sequential dynamics of large-scale brain network activation.
Clinical Assessments
Before initiation of ECT, all patients will undergo a comprehensive clinical evaluation including a sociodemographic data form, ECT follow-up form, Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Montgomery-Åsberg Depression Rating Scale (MADRS), Beck Scale for Suicide Ideation (BSSI), Clinical Global Impression Scale (CGI), Center for Epidemiologic Studies Depression Scale (CES-D), Cumulative Illness Rating Scale-Geriatric (CIRS-G), Maudsley Staging Scale (MSS), and Mini-Mental State Examination (MMSE).
Rating scales will be administered at each EEG assessment time point, whereas clinical follow-up forms will be completed throughout the treatment period. Treatment response will be defined as a reduction of at least 50% in the baseline HAM-D-17 score, while remission will be defined as a HAM-D-17 score below 7.
Peripheral venous blood samples will be collected from all patients at three time points: before the first ECT session (between 07:30 and 09:30 a.m. under fasting conditions), two weeks after completion of the ECT course, and eight weeks after treatment completion.
Blood samples will be collected into 10-mL K2EDTA tubes (BD, UK), centrifuged at 4,000 rpm for 10 minutes, and plasma aliquots will be stored at -80°C until biochemical analyses are performed.
Complete blood count parameters together with inflammatory biomarkers including pro-inflammatory and anti-inflammatory cytokines, C-reactive protein (CRP), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and monocyte-to-lymphocyte ratio (MLR) will be analyzed.
Age-matched healthy volunteers will also be recruited. Healthy controls will complete a sociodemographic questionnaire, MMSE, BDI, and BAI. A single resting-state EEG recording consisting of 5 minutes with eyes open and 5 minutes with eyes closed will be obtained. Peripheral blood samples will also be collected for inflammatory biomarker analyses using the same laboratory procedures as those applied to the patient group.
Sample size estimation was performed using G*Power version 3.1.9 (Faul et al., 2009). Based on an effect size of 0.70 and a statistical power (1-β) of 0.85, the required sample size was calculated to be 31 patients and 31 healthy controls. The power analysis was based on clinical treatment response as the primary outcome measure.
The study population will consist of older-age patients diagnosed with Major Depressive Episode who are scheduled to receive electroconvulsive therapy at the Department of Psychiatry, Cerrahpaşa Faculty of Medicine, Istanbul University-Cerrahpaşa, and who voluntarily agree to participate in the study.
EEG preprocessing and microstate analyses will be performed using EEGLAB implemented in MATLAB. Statistical analyses will be conducted using IBM SPSS Statistics version 27.
Continuous variables will be presented as mean ± standard deviation or median (interquartile range), depending on data distribution, whereas categorical variables will be summarized as frequencies and percentages.
Normality of continuous variables will be assessed using the Shapiro-Wilk test.
For comparisons of repeated measurements obtained before ECT, two weeks after ECT, and two months after ECT, repeated-measures analysis of variance (repeated-measures ANOVA) will be used for normally distributed variables. When the assumptions for parametric testing are not met, the Friedman test will be performed. Pairwise comparisons will be adjusted using appropriate post hoc correction methods.
Comparisons between patients and healthy controls will be performed using the independent-samples Student's t-test or the Mann-Whitney U test, depending on data distribution.
Categorical variables will be analyzed using the Chi-square test or Fisher's exact test, as appropriate.
Correlations between continuous variables, including EEG microstate parameters, inflammatory biomarkers, and psychometric scale scores, will be evaluated using Pearson's or Spearman's correlation coefficients, depending on the data distribution.
To identify independent predictors of treatment response, multivariable logistic regression analysis will be performed. Statistical significance will be defined as a two-sided p-value \< 0.05.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's planned enrollment of 62 is below the median of 159 across 348 observational studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Istanbul University - Cerrahpasa is the lead sponsor of 699 studies on the registry; 213 are open to participants now.
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Patients with Major Depressive Disorder or Bipolar Disorder Major Depressive Episode who were suggested ECT clinically and 55 years of age or older, and sociodemographically compatible healthy controls who are 55 years of age or older and do not have a known neuropsychiatric diagnosis at the time of research.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient Group
Healthy Control Group:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
People over 55 years of age who were diagnosed with Major Depressive Episode, whose diagnosis is either Major Depression or Bipolar Depression
Device: Electroconvulsive Therapy
The healthy control group will consist of age- and sex-matched volunteers who are 55 years of age or older, who do not use any medication that may significantly influence EEG activity or inflammatory biomarkers, and who do not have a current neurological or psychiatric disorder. Healthy controls will also provide written informed consent before participation. EEG recordings will be obtained once and will serve as reference data for normal brain activity.
ECT will be administered using the Thymatron System IV Integrated ECT Device under general anesthesia according to standard clinical protocols. Treatments will be delivered using bilateral electrode placement (or right unilateral if side effects are observed) with brief-pulse squarewave stimulation. The duration of treatment, number of sessions, and stimulation parameters will be determined according to each patient's clinical condition.
Clinical Response and Remission Assessed by the Montgomery-Åsberg Depression Rating Scale
Before ECT initiation and 2 and 8 weeks after the cessation of ECT sessions, depressive symptom severity will be assessed using the Montgomery-Åsberg Depression Rating Scale. Montgomery-Åsberg Depression Rating Scale total score ranges from 0 to 60, with higher scores indicating greater severity of depressive symptoms. Change in total score from baseline will be assessed following electroconvulsive therapy (ECT).Clinical response will be defined as a ≥50% reduction in MADRS total score from baseline. Remission will be defined as a MADRS total score ≤7.
Time frame: 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
Before ECT initiation and 2 and 8 weeks after the cessation of ECT sessions, depressive symptom severity will be assessed using the Hamilton Depression Rating Scale. The total score of scale ranges from 0 to 52, with higher scores indicating greater severity of depressive symptoms. Change in Hamilton Depression Rating Scale total score from baseline will be assessed following electroconvulsive therapy (ECT).Clinical response will be defined as a ≥50% reduction in total score from baseline. Remission will be defined as a total score ≤7.
Time frame: 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
Participants will be instructed to remain relaxed, quiet, and motionless during EEG recording. EEG acquisition will consist of 5 minutes with eyes open followed by 5 minutes with eyes closed. Raw EEG data will undergo preprocessing, including artifact removal, band-pass filtering, and re-referencing. Microstate analysis will be performed using MICROSTATELAB v2.1, an EEGLAB extension. Four canonical microstate classes (A, B, C, and D) will be identified. For each microstate class, duration will be calculated as the mean time for which the microstate remains stable following its onset and will be reported in milliseconds (ms).
Time frame: 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 Occurrence
Participants will be instructed to remain relaxed, quiet, and motionless during EEG recording. EEG acquisition will consist of 5 minutes with eyes open followed by 5 minutes with eyes closed. Raw EEG data will undergo preprocessing, including artifact removal, band-pass filtering, and re-referencing. Microstate analysis will be performed using MICROSTATELAB v2.1, an EEGLAB extension. Four canonical microstate classes (A, B, C, and D) will be identified. For each microstate class, occurrence will be calculated as the mean number of times the microstate occurs per second and will be reported in Hertz (Hz).
Time frame: 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 Coverage
Participants will be instructed to remain relaxed, quiet, and motionless during EEG recording. EEG acquisition will consist of 5 minutes with eyes open followed by 5 minutes with eyes closed. Raw EEG data will undergo preprocessing, including artifact removal, band-pass filtering, and re-referencing. Microstate analysis will be performed using MICROSTATELAB v2.1, an EEGLAB extension. Four canonical microstate classes (A, B, C, and D) will be identified. For each microstate class, coverage will be calculated as the percentage of the total EEG recording time occupied by that microstate class and will be reported as a percentage (%).
Time frame: 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 Transition Probability
Participants will be instructed to remain relaxed, quiet, and motionless during EEG recording. EEG acquisition will consist of 5 minutes with eyes open followed by 5 minutes with eyes closed. Raw EEG data will undergo preprocessing, including artifact removal, band-pass filtering, and re-referencing. Microstate analysis will be performed using MICROSTATELAB v2.1, an EEGLAB extension. Four canonical microstate classes (A, B, C, and D) will be identified. For each pair of microstate classes, transition probability will be calculated as the proportion of transitions from a given microstate class to a specific subsequent microstate class relative to all transitions originating from that microstate class. Transition probability will be reported as a proportion ranging from 0 to 1.
Time frame: These assessments will be repeated within 1 week before ECT starts, and at 14+6 days and 8 weeks + 6 days after ECT cessation.
Correlation between baseline neuroinflammatory biomarkers and treatment response
Correlation coefficients between baseline concentrations of neuroinflammatory biomarkers and change in Hamilton Depression Rating Scale scores following ECT will be calculated.
Time frame: 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 Center for Epidemiologic Studies Depression Scale
Depressive symptoms will be assessed using the Center for Epidemiologic Studies Depression Scale before ECT initiation and at 2 and 8 weeks after the cessation of ECT sessions. The scale consists of 20 items, with a total score ranging from 0 to 60; higher scores indicate greater severity of depressive symptoms. Changes in the total scores from baseline will be evaluated following ECT.
Time frame: These assessments will be repeated within 1 week before ECT start and 14+6 days and 8 weeks + 6 days after ECT cessation.
Correlation between changes in neuroinflammatory biomarkers and EEG microstate parameters
Correlation coefficients between changes in neuroinflammatory biomarker concentrations and changes in EEG microstate parameters (duration, occurrence, coverage, and transition probabilities) following ECT will be calculated.
Time frame: These assessments will be repeated within 1 week before ECT starts, and at 14+6 days and 8 weeks + 6 days after ECT cessation.
Inflammatory indices derived from complete blood count
Neutrophil-to-Lymphocyte Ratio (NLR) will be calculated from complete blood count parameters and expressed as a ratio.
Time frame: These assessments will be repeated within 1 week before ECT starts, and at 14+6 days and 8 weeks + 6 days after ECT cessation.
Inflammatory indices derived from complete blood count
Platelet-to-Lymphocyte Ratio (PLR) will be calculated from complete blood count parameters and expressed as a ratio.
Time frame: These assessments will be repeated within 1 week before ECT starts and 14+6 days and 8 weeks + 6 days after ECT cessation.
Inflammatory indices derived from complete blood count
Monocyte-to-Lymphocyte Ratio (MLR) will be calculated from complete blood count parameters and expressed as a ratio.
Time frame: These assessments will be repeated within 1 week before ECT starts and 14+6 days and 8 weeks + 6 days after ECT cessation.
Correlation between baseline neuroinflammatory biomarkers and treatment response
Correlation coefficients between baseline concentrations of neuroinflammatory biomarkers and change in Montgomery-Asberg Depression Rating Scale scores following ECT will be calculated.
Time frame: These assessments will be repeated within 1 week before ECT starts and 14+6 days and 8 weeks + 6 days after ECT cessation.
Clinical Response Assessed by Beck Depression Inventory
Depressive symptoms will be assessed using the Beck Depression Inventory before ECT initiation and at 2 and 8 weeks after the cessation of ECT sessions. The Beck Depression Inventory consists of 21 items, with a total score ranging from 0 to 63; higher scores indicate greater severity of depressive symptoms. A ≥50% reduction in the total score from baseline will be used to define treatment response, and a total score ≤9 will be used to define remission.
Time frame: These assessments will be repeated within 1 week before ECT starts, and 14+6 days and 8 weeks + 6 days after ECT cessation.
Clinical Response Assessed by Beck Anxiety Scale
Anxiety symptoms will be assessed using the Beck Anxiety Inventory before ECT initiation and at 2 and 8 weeks after the cessation of ECT sessions. The Beck Anxiety Inventory consists of 21 items, with a total score ranging from 0 to 63; higher scores indicate greater severity of anxiety symptoms. A ≥50% reduction in the total score from baseline will be used to define treatment response, and a total score ≤10 will be used to define remission.
Time frame: These assessments will be repeated within 1 week before ECT starts and 14+6 days and 8 weeks + 6 days after ECT cessation.
Clinical Response Assessed by Hamilton Anxiety Scale
Anxiety symptoms will be assessed using the Hamilton Anxiety Rating Scale before ECT initiation and at 2 and 8 weeks after the cessation of ECT sessions. The Hamilton Anxiety Rating Scale consists of 14 items, with a total score ranging from 0 to 56; higher scores indicate greater severity of anxiety symptoms. A ≥50% reduction in the total score from baseline will be used to define treatment response, and a total score ≤7 will be used to define remission.
Time frame: 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 Beck Scale for Suicidal Ideation
Suicidal ideation will be assessed using the Beck Scale for Suicide Ideation before ECT initiation and at 2 and 8 weeks after the cessation of ECT sessions. The Beck Scale for Suicide Ideation consists of 19 scored items, with a total score ranging from 0 to 38; higher scores indicate greater severity of suicidal ideation. A ≥50% reduction in the Beck Scale for Suicide Ideation total score from baseline will be used to define treatment response, and a total score ≤6 will be used to define remission.
Time frame: 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 Clinical Global Impression- Severity
Overall illness severity will be assessed using the Clinical Global Impression-Severity scale before ECT initiation and at 2 and 8 weeks after the cessation of ECT sessions. The scale is a 7-point clinician-rated scale ranging from 3 to 18, with higher scores indicating greater overall illness severity. Changes in CGI-S the scale scores from baseline will be evaluated following ECT.
Time frame: These assessments will be repeated within 1 week before ECT start and 14+6 days and 8 weeks + 6 days after ECT cessation.
Concentration of peripheral neuroinflammatory biomarkers
Concentrations of soluble glycoprotein 130 (sgp130) and soluble interleukin-6 receptor (sIL-6R) will be measured from peripheral blood samples using ELISA assays. (ng/ml).
Time frame: These assessments will be repeated within 1 week before ECT starts, and at 14+6 days and 8 weeks + 6 days after ECT cessation.
Concentration of peripheral neuroinflammatory biomarkers
Concentrations of IL-1α, IL-1β, IL-2, IL-6, IL-8, IL-10, TNF-α, interferon gamma-induced protein-10 (IP-10), will be measured from peripheral blood samples using ELISA assays ( pg/mL).
Time frame: These assessments will be repeated within 1 week before ECT starts, and at 14+6 days and 8 weeks + 6 days after ECT cessation.
Concentration of peripheral neuroinflammatory biomarkers
Concentrations of C-reactive protein (CRP) will be measured from peripheral blood samples using ELISA assays ( mg/L).
Time frame: 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 Cognitive Assessment
Cognitive function will be assessed using the Mini-Mental State Examination before ECT initiation and at 2 and 8 weeks after the cessation of ECT sessions. The scale is a clinician-administered cognitive assessment with a total score ranging from 0 to 30, with higher scores indicating better cognitive function. Changes in the total scores from baseline will be evaluated following ECT.
Time frame: These assessments will be repeated within 1 week before ECT start and 14+6 days and 8 weeks + 6 days after ECT cessation.
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