Electroconvulsive Therapy Versus Intravenous Ketamine in Treatment-Resistant Major Depressive Disorder

Tanta University70 enrolled

Overview

This study aimed to compare the efficacy, safety, and tolerability of electroconvulsive therapy (ECT) versus intravenous (IV) ketamine in adults with treatment-resistant major depressive disorder (TRD).

Treatment resistant depression is defined as a lack of adequate response to at least two antidepressant trials of sufficient dose, duration, and adherence in the current depressive episode. Recent studies estimate treatment-resistant depression (TRD) by 30% of people with major depressive disorder (MDD) leading to significant challenges in care. This condition can increase disability, healthcare costs, and suicide risk, making effective treatments crucial.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Electroconvulsive Therapy Intravenous Ketamine Treatment-Resistant Major Depressive Disorder

Interventions

Electroconvulsive TherapyDRUG

Patients received Bitemporal electroconvulsive Therapy (ECT) (2x/week for 4 weeks).

KetamineDRUG

Patients received intravenous (IV) ketamine 0.5 mg/kg IV infusion over 40 mins (2x/week for 4 weeks).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults aged 18-75 years. * Current diagnosis of major depressive disorder (MDD) according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. * Treatment resistance defined as failure to respond to ≥2 adequate antidepressant trials in the current episode. * Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥20. * Capacity to provide informed consent. Exclusion Criteria: * History of psychotic disorders or bipolar disorder. * Current substance use disorder. * Significant neurological disorders or traumatic brain injury. * Uncontrolled hyper- tension. * cardiovascular diseases in the past six months. * Pregnancy or breastfeeding.

Locations (1)

Tanta University

Tanta, El-Gharbia, Egypt

Outcomes

Primary Outcomes

Change in Montgomery-Åsberg Depression Rating Scale

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) was recorded from baseline to end of 3-week treatment period. The MADRS comprises the following 10 items: (1) apparent sadness; (2) reported sadness; (3) inner tension; (4) reduced sleep; (5) reduced appetite; (6) concentration difficulties; (7) lassitude; (8) inability to feel; (9) pessimistic thoughts; and (10) suicidal thoughts. With a, maximum score of 60, where higher scores indicate greater severity

Time frame: 3 weeks post-procedure

Secondary Outcomes

Montreal Cognitive Assessment (MoCA)

Montreal Cognitive Assessment (MoCA) for cognitive function was recorded from baseline to end of 3-week treatment period. MoCA is a rapid, 10-15 minute screening tool used to detect mild cognitive impairment (MCI) and early dementia, scoring a maximum of 30 points, with a score of 26 or higher considered normal.

Time frame: 3 weeks post-procedure

Patient Health Questionnaire-9 (PHQ-9)

The Patient Health Questionnaire-9 (PHQ-9) is a 9-item, self-administered diagnostic tool used by clinicians to screen for the presence and severity of depression. It assesses symptoms over the past two weeks based on DSM-IV criteria, with scores ranging from 0 to 27, where higher scores indicate greater depression severity.

Time frame: 3 weeks post-procedure

Data from ClinicalTrials.gov

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