Clinical TrialTreatment-Resistant Depression (TRD)PlaceboKetamineCompleted

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

This randomised, open-label, parallel-group trial (n=70) will evaluate the efficacy, safety and tolerability of bitemporal electroconvulsive therapy (ECT) versus intravenous ketamine in adults with treatment-resistant major depressive disorder (TRD). The study will recruit adults aged 18-75 years with major depressive disorder who have not responded to at least two adequate antidepressant trials in the current episode and have a Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 20. Participants will receive either bitemporal ECT twice weekly for 4 weeks or intravenous ketamine 0.5 mg/kg infused over 40 minutes twice weekly for 4 weeks. The primary outcome is change in MADRS score 3 weeks post-procedure. Exclusion criteria include psychotic or bipolar disorder, current substance use disorder, significant neurological disease or traumatic brain injury, uncontrolled hypertension, recent cardiovascular disease, and pregnancy or breastfeeding.

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Target Enrollment
70 participants
Study Type
Phase NA interventional
Design
Randomized

Detailed Description

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 Arms & Interventions

ECT Group

experimental

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

Interventions

  • Placebo
    • 2x/week for 4 weeks• 8 doses total

    Unmatched intervention: 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).

Interventions

  • Ketamine0.5 mg/kg
    via IV• 2x/week for 4 weeks• 8 doses total

Participants

Ages
18 – 75
Sexes
Male & Female

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 Details

Locations

Tanta University — Tanta, El-Gharbia, Egypt