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

NCT06439797 | Completed

• 1 other identifier: 5040-18-SMC
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder; Healty Controls

Outcome Measures

Primary Outcomes (1)

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

  Patients, ages 18-70, with the diagnosis of treatment-resistant depression will recruited. Participants will undergo psychiatric and psychological assessments, before (baseline) and 12 weeks after ECT initiation. Assessments included 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 weeks end-of-treatment time points for molecular analysis.

  Before ECT treatment and after 12 treatments, After 3 weeks

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Major Depressive Disorder with treatment-resistant disorder referred to the ECT clinic

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Chaim Sheba Medical Center: lead
• Hebrew University of Jerusalem: collaborator

Study Sites (1)

Revital Amiaz

Ramat Gan, RI, 52621, Israel

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Psychiatry Department B, The Chaim Sheba Medical Center

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: November 29, 2018
• Primary Completion: July 9, 2020
• Study Completion: July 9, 2020
• Last Updated: June 3, 2024

Record last verified: 2024-05

Locations

IL (1)