CompletedNot Applicable

Inflammatory Markers as Predictors of the Efficacy of Electroconvulsive Therapy (ECT) in Major Depression Patients

Israel18 participantsStarted 2018-11-29

Plain-language summary

Background: ECT is an effective treatment indicated for patients with treatment resistant depression. Although most patients display some degree of recovery, 32-52% do not respond or remit at all. Considering the possible side effects and the considerably high cost of treatment, it is important to identify sub-populations that would benefit the most from ECT. In the current study we sought to identify predictive molecular markers in the blood of depressed patients who are responsive to ECT. Methods: Patients, ages 18-70, with the diagnosis of treatment-resistant depression will be recruited. Participants will undergo psychiatric and psychological assessments, before (baseline) and 12 weeks after ECT initiation. Assessments will include the Montgomery-Asberg Depression Rating Scale (MADRAS), Clinical Global Improvement and Severity Scales (CGI-S, CGI-I), Inventory of Depressive Symptomatology (IDS), and the State-Trait Anxiety Inventory (STAI). Blood samples for serum and isolation of peripheral blood mononuclear cells (PBMCs)will be collected at baseline and the 12-week end-of-treatment time points for molecular analysis.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Capable and willing to provide informed consent. Able to adhere to the treatment schedule. Are treated for the current depressive episode, at least four weeks, with at least one antidepressant in accepted dose, without improvement, according to their medical chart and ATHF (antidepressant treatment history form) instruction guidelines. Exclusion Criteria: * Diagnosis of an autoimmune disease. History of disturbances with bone marrow functioning. History of Oncologic Diseases. History of drug abuse or alcoholism in the last 6 months. Suffering from another diagnosis on axis 1, including schizophrenia, and geriatric depression. Patients with any current unstable medical illness. Any condition involving fluid retention, pulmonary infiltrates, congestive heart failure, respiratory symptoms or disease, cardiac symptoms or disease, and renal or hepatic dysfunction Patients taking lithium or corticosteroids. Pregnancy or not using a reliable method of birth control. Neurodegenerative diseases (i.e: Alzheimer's disease, Parkinson's disease). Participation in a current interventional clinical study or interventional clinical study within 30 days before this study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Inflammatory Markers as Predictors of the efficacy of Electroconvulsive Therapy (ECT) in Major Depression Patients.

Timeframe: Before ECT treatment and after 12 treatments, After 3 weeks

Trial details

NCT IDNCT06439797

SponsorThe Chaim Sheba Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-07-09

View on ClinicalTrials.gov More Major Depressive Disorder trials