Clinical TrialMajor 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.

Target Enrollment
48 participants
Study Type
Phase IV interventional
Design
Randomized, quadruple 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 Details

Locations

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

Your Library