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Completed

NCT Number: NCT07526454

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).

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Key information

Conditions

Electroconvulsive Therapy Depressive Disorder Depressive Disorder, Major Intravenous Ketamine Major Depressive Disorder Mental Disorders Mood Disorders Treatment-Resistant

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electroconvulsive Therapy

Drug

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

ketamine

Drug

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

Primary outcomes

  1. Change in Montgomery-Åsberg Depression Rating Scale

    Time frame: 3 weeks post-procedure

    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

Secondary outcomes

  1. Montreal Cognitive Assessment (MoCA)

    Time frame: 3 weeks post-procedure

    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.

  2. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 3 weeks post-procedure

    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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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