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

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

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).

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder; Electroconvulsive Therapy; Treatment-Resistant; Intravenous Ketamine
• Intervention / Treatment: Drug: Electroconvulsive Therapy; Drug: Ketamine

Detailed Description

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
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ECT Group; Patients received Bitemporal electroconvulsive Therapy (ECT) (2x/week for 4 weeks).	Drug: Electroconvulsive Therapy; Patients received Bitemporal electroconvulsive Therapy (ECT) (2x/week for 4 weeks).
Active Comparator: Ketamine Group; Patients received intravenous (IV) ketamine 0.5 mg/kg IV infusion over 40 mins (2x/week for 4 weeks).	Drug: Ketamine; Patients received intravenous (IV) ketamine 0.5 mg/kg IV infusion over 40 mins (2x/week for 4 weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 weeks post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 weeks post-procedure

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): February 1, 2026
• Study Completion (Actual): February 1, 2026

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Organic Chemicals; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Behavioral Disciplines and Activities; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; Ketamine; Electroconvulsive Therapy
• Other Study ID Numbers: 36264PR1275/7/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No