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

NCT07526454 | Completed

• 1 other identifier: 36264PR1275/7/25
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Electroconvulsive Therapy; Intravenous Ketamine; Treatment-Resistant; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Montreal Cognitive Assessment (MoCA)

  3 weeks post-procedure

• Patient Health Questionnaire-9 (PHQ-9)

  3 weeks post-procedure

Study Arms (2)

ECT Group

EXPERIMENTAL

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

Drug: Electroconvulsive Therapy

Ketamine Group

ACTIVE COMPARATOR

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

Drug: Ketamine

Interventions

Electroconvulsive Therapy DRUG

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

ECT Group

Ketamine DRUG

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

Ketamine Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Electroconvulsive Therapy; Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecture of Neurology and Psychiatry, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: July 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)