Clinical TrialParallelMajor Depressive Disorder (MDD)KetaminePlaceboCompleted

Effects of Low-dose Ketamine as an Adjunct to Propofol-based Anesthesia for Electroconvulsive Therapy

Proof-of-concept randomised, placebo-controlled trial (n=48) testing low-dose ketamine (0.2 mg/kg; possible escalation to 0.5 mg/kg) as an adjunct to propofol-based anaesthesia for ECT in adults with major depressive disorder.

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Target Enrollment
48 participants
Study Type
Phase IV interventional
Design
Randomized, double Blind

Detailed Description

Randomised, parallel-group study comparing propofol induction with adjunct low-dose ketamine versus propofol with saline placebo in patients referred for ECT for major depressive disorder; total sample n=48.

Patients receive ECT up to three times per week for a maximum of 12 treatments; outcomes include depressive symptoms (MADRS), recovery characteristics, vital signs, and adverse events; an interim analysis after 14 patients could trigger dose escalation to 0.5 mg/kg.

Study Protocol

Preparation

sessions

Dosing

12 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Propofol induction with addition of low-dose ketamine (0.2 mg/kg; possible escalation to 0.5 mg/kg per interim analysis).

Interventions

  • Ketamine0.2 - 0.5 mg/kg
    via IV• per ECT session• 12 doses total

    Administered with usual propofol induction (0.75–1 mg/kg)

Placebo

inactive

Propofol induction with normal saline placebo.

Interventions

  • Placebo
    via IV• per ECT session• 12 doses total

    Normal saline administered with usual propofol induction

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • referred for ECT with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of major depressive disorder
  • considered American Society of Anesthesiologists (ASA) Physical Class I - III
  • baseline MADRS score greater than 24 (i.e. at least moderate to severe depression)
  • a "first" or "new" episode of depression which has lasted not more than 3 months and requires ECT treatment as judged by a psychiatrist

Exclusion Criteria

  • Exclusion Criteria:
  • ASA Class IV or V as judged by the anesthesiologist
  • Any ECT treatment in the previous three months
  • Inability or refusal to provide informed consent
  • A history of allergic reactions, hypersensitivity, or intolerance to anesthetics or their constituents used in the study (ketamine, propofol, egg phosphatide, soybean oil)
  • Anyone taking medications considered contraindicated for ECT or for general anesthesia
  • Presence of any of the following DSM-IV diagnoses: Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), abuse of opiates, amphetamines, barbiturates, cocaine, cannabis, or hallucinogen abuse in the 4 weeks prior to enrolment, pervasive developmental disorder, dementia
  • Significant medical condition that would contraindicate the use of ketamine, propofol or that is untreated and would need urgent attention (as determined by treating physician)
  • Medical conditions that would significantly affect absorption, distribution, metabolism, or excretion of ketamine or propofol
  • Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
  • Patients with increased risk of laryngospasm (such as active pulmonary infection, upper respiratory infection, asthma), increased intracranial pressure, glaucoma, thyroid disease/hyperthyroidism
  • Any clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator
  • Pregnancy (or female of child-bearing age not using adequate contraception) or lactation
  • Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements

Study Protocol, Arms & Participants

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Study Details

Study Team

Sponsors & Collaborators

Locations

Alberta Hospital Edmonton — Edmonton, Alberta, Canada
University of Alberta Hospital — Edmonton, Alberta, Canada

Related Publications

PaywallindividualPrimary

Low-dose ketamine does not improve the speed of recovery from depression in electroconvulsive therapy: a randomized controlled trial

This randomised, double-blind, placebo-controlled study investigated the efficacy of using low-dose ketamine (35mg/70kg) as an anaesthetic adjunct to propofol during electroconvulsive therapy (ECT) for treating patients with depression (MDD). Adding ketamine did not alter the antidepressant efficacy or the hemodynamics of electroconvulsive therapy, although it may help reduce the dose requirements of propofol anaesthesia.

Published
Journal
brazilian Journal of Psychiatry
Authors
Woolsey, A. J., Nanji, J. A., Moreau, C., Sivapalan, S., Bourque, S. L., Ceccherini-Nelli, A., Gragasin, F. S.

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