Clinical TrialTreatment-Resistant Depression (TRD)KetaminePlaceboCompleted

Comparing Ketamine and Propofol Anesthesia for Electroconvulsive Therapy

Randomised, quadruple-blind, parallel Phase IV study (n=27) comparing ketamine (0.75 mg/kg IV) versus propofol (1 mg/kg IV) as anaesthetic agents for ECT in treatment-resistant major depressive disorder.

Target Enrollment
27 participants
Study Type
Phase IV interventional
Design
Randomized, quadruple Blind

Detailed Description

This parallel-group randomised trial tests whether ketamine as the anaesthetic for ECT improves depressive symptoms compared with propofol in patients with treatment-resistant depression.

Patients receive anaesthesia with ketamine 0.75 mg/kg IV or propofol 1 mg/kg IV, both with remifentanil 1 mcg/kg; efficacy assessed by MADRS and clinical measures.

Planned interim safety analyses were described after 20 and 40 patients; an independent safety committee reviews adverse events and may adjust dosing or discontinue the trial.

Study Arms & Interventions

Ketamine

experimental

Ketamine anesthesia for ECT with remifentanil co-administration.

Interventions

  • Ketamine0.75 mg/kg
    via IV• per ECT session

    Ketamine 0.75 mg/kg IV with remifentanil 1 mcg/kg IV.

Propofol

active comparator

Propofol anesthesia for ECT with remifentanil co-administration.

Interventions

  • Placebo1 mg/kg
    via IV• per ECT session

    Propofol 1 mg/kg IV with remifentanil 1 mcg/kg IV; comparator stored as placeholder compound.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:\n* Fulfill the diagnostic criteria for major depression according to the Diagnostic and Statistical Manual of Mental Disorders (most recent edition)\n* Failure to respond to at least 2 adequate drug therapies for the current depression episode\n* MADRS score of 20 or above (moderate - severe)\n* ASA physical status classification I to III

Exclusion Criteria

  • Exclusion Criteria:\n* Inability to obtain informed consent\n* ASA physical status classification IV\n* Complication by any serious physical diseases such as cardiovascular disease (including untreated HTN), respiratory disease, cerebrovascular disease, intracranial HTN (including glaucoma), or seizures\n* Presence of foreign body (including pacemaker)\n* Pregnancy\n* Allergies to anesthetics used in study Includes: a) Ketamine b) Propofol c) Eggs d) Egg products e) Soybeans f) Soy products

Study Details

Locations

Royal University Hospital — Saskatoon, Saskatchewan, Canada

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