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Comparing Ketamine and Propofol Anesthesia for Electroconvulsive Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01935115
First Posted: September 4, 2013
Last Update Posted: September 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Saskatoon Health Region
Royal University Hospital Foundation
Schulman Research Award
Information provided by (Responsible Party):
Jonathan Gamble, University of Saskatchewan
August 26, 2013
September 4, 2013
September 13, 2017
September 2013
March 2016   (Final data collection date for primary outcome measure)
The primary outcome is defined as the number of ECT treatments required to reach a 50% reduction in baseline MADRS (Montgomery-Asberg Depression Scale) score. [ Time Frame: After 8 treatments or completion of therapy for an expected average of 4 weeks ]
Standard of care for ECT in the Saskatoon Health Region are biweekly sessions for a total of 8 treatments. Occasionally, a patient meets early remission and may not require the full 8 treatments and may be eligible for early withdrawal.
Same as current
Complete list of historical versions of study NCT01935115 on ClinicalTrials.gov Archive Site
  • Change in CADSS (Clinician Administered Dissociative States Scale) [ Time Frame: 30 minutes after each ECT session and one day after each ECT session for an expected average of 4 weeks ]
    The CADSS is used to assess states of clinical dissociation; a potential side effect of ketamine. A baseline CADSS will be obtained one day prior to start of ECT. Additional scores will be assessed 30 minutes after each therapy as well as one day post-therapy on the ward.
  • Change in ALS-18 (Affective Lability Scale) [ Time Frame: 30 days after final ECT session for an expected average duration of 2 months ]
    A baseline ALS-18 score will be obtained. 30 days after completion of therapy, another score will be collected.
  • Change in ECT energy settings and seizure quality [ Time Frame: Within 30 minutes of each treatment for an expected average of 4 weeks ]
    We will document energy settings used by the psychiatrist as well as duration and quality of seizures achieved.
  • Hemodynamic instability and respiratory complications [ Time Frame: 1 hour after each ECT for an expected average of 4 weeks ]
    Any hemodynamic or respiratory instability requiring unanticipated intervention will be recorded as well as the treatment for the event recorded. Type of intervention will also be documented.
  • Time to discharge [ Time Frame: 1 hour after each treatment for an expected average of 4 weeks ]
    Total time spend in the post-anesthetic recovery unit will be recorded.
  • Change in MADRS score [ Time Frame: 24 hours after each treatment and 30 days after final treatment for an expected average of 2 months ]
    A baseline MADRS score will be conducted one day prior to ECT. Additional scores will be obtained one day after each ECT session. A final MADRS score will be assessed 30 days after completion of ECT.
  • The number of ECT sessions required to achieve depression remission (MADRS ≤10) [ Time Frame: Number of ECT treatments to achieve depression remission (MADRS) or completion of therapy up to 4 weeks ]
    Standard of care for ECT in the Saskatoon Health Region are biweekly sessions for a total of 8 treatments. Occasionally, a patient meets early remission and may not require the full 8 treatments and may be eligible for early withdrawal.
  • The proportion of depressed patients (MADRS > 20) at 30 days after the last ECT session [ Time Frame: 30 days after the last ECT session, up to 60 days after ECT initiation. ]
    The proportion of patients in each group who have severe depression 30 days after their last ECT session. This is a measure of longer term efficacy of treatment effect.
  • Change in systolic blood pressure [ Time Frame: During ECT, up to 8 treatments or 4 weeks ]
    Increases or decreases in baseline systolic blood pressure at any point during the anesthetic care will be categorically recorded as minimal change (20 - 50 mm Hg from baseline) and significant change (more than 50 mm Hg from baseline)
  • Change in CADSS (Clinician Administered Dissociative States Scale) [ Time Frame: 30 minutes after each ECT session and one day after each ECT session for an expected average of 4 weeks ]
    The CADSS is used to assess states of clinical dissociation; a potential side effect of ketamine. A baseline CADSS will be obtained one day prior to start of ECT. Additional scores will be assessed 30 minutes after each therapy as well as one day post-therapy on the ward.
  • Change in ALS-18 (Affective Lability Scale) [ Time Frame: 30 days after final ECT session for an expected average duration of 2 months ]
    A baseline ALS-18 score will be obtained. 30 days after completion of therapy, another score will be collected.
  • Change in ECT energy settings and seizure quality [ Time Frame: Within 30 minutes of each treatment for an expected average of 4 weeks ]
    We will document energy settings used by the psychiatrist as well as duration and quality of seizures achieved.
  • Hemodynamic instability and respiratory complications [ Time Frame: 1 hour after each ECT for an expected average of 4 weeks ]
    Any hemodynamic or respiratory instability requiring unanticipated intervention will be recorded as well as the treatment for the event recorded. Type of intervention will also be documented.
  • Time to discharge [ Time Frame: 1 hour after each treatment for an expected average of 4 weeks ]
    Total time spend in the post-anesthetic recovery unit will be recorded.
  • Change in MADRS score [ Time Frame: 24 hours after each treatment and 30 days after final treatment for an expected average of 2 months ]
    A baseline MADRS score will be conducted one day prior to ECT. Additional scores will be obtained one day after each ECT session. A final MADRS score will be assessed 30 days after completion of ECT.
Not Provided
Not Provided
 
Comparing Ketamine and Propofol Anesthesia for Electroconvulsive Therapy
A Prospective Randomized Double Blinded Control Trial Using Ketamine or Propofol Anesthesia for Electroconvulsive Therapy: Improving Treatment-Resistant Depression
To determine the effect of ketamine, compared to propofol, when used an an anesthetic agent for electroconvulsive therapy (ECT) in the treatment of major depressive disorder (MDD). We hypothesize that ketamine, compared to propofol, will improve the the symptoms of MDD when used as the anesthetic agent to facilitate ECT. Additionally, we hypothesize the dissociative and cardiovascular effects of ketamine will be minimal.

Treatment resistant depression is a common and disabling condition. The delayed onset of action and side effects exhibited by oral antidepressants are significant limitations. An alternative and well-established therapy is electroconvulsive therapy (ECT). ECT has rapid antidepressant effect beginning with the completion of the first session. Nevertheless, like oral medications, patients treated with ECT can develop treatment resistance or failure to respond. There is great need for a novel approach to treatment-resistant depression; one that that is safe, has rapid onset, and is sustained.

Pharmaceutical agents with rapid antidepressant effects are a new and promising paradigm in the research for treatment of MDD. A potential therapeutic target is glutamate based signal transmission because glutamate transmission is abnormally regulated in the limbic/cortical areas of many depressed people. Glutamatergic modulating agents, in particular ketamine, have been shown to induce rapid antidepressant effects both in both preclinical models and humans. Additionally, ketamine has been shown to have persistent antidepressive effect.

Presently worldwide, propofol is one of the most commonly used anesthetic agents for ECT. There are 2 main disadvantages to this practice. First, propofol has no antidepressive effect. Second, propofol is a potent anticonvulsant that may worsen the quality of the ECT induced seizures. A recent open-label trial compared ketamine to propofol for anesthesia during ECT and demonstrated a significant improvement of depression in the ketamine arm. Ketamine is routinely used to provide safe general anesthesia as well as procedural sedation, analgesia, and amnesia. The combination of the intrinsic antidepressant effects of ketamine with electroconvulsive therapy is a promising concept in clinical research.

This study will include planned interim analysis to ensure patients safety. This analysis will be performed by a statistician who is blinded to group allocation after 20 and after 40 patients. An independent safety committee will informed of the results of the interim analysis including side effects and complications and will have the option to adjust the drug dosage or to discontinue the trial.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Treatment Resistant Depression
  • Drug: Propofol
    Propofol anesthesia for ECT
    Other Name: Diprivan
  • Drug: Ketamine
    Ketamine anesthesia for ECT
    Other Name: Ketalar
  • Active Comparator: Propofol
    The control group will receive propofol 1 mg/kg and remifentanil 1 mcg/kg intravenously
    Intervention: Drug: Propofol
  • Experimental: Ketamine
    Study group will receive ketamine 0.75 mg/kg and remifentanil 1 mcg/kg intravenously
    Intervention: Drug: Ketamine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
March 2016
March 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Inability to obtain informed consent
  • ASA physical status classification IV
  • Complication by any serious physical diseases such as cardiovascular disease (including untreated HTN), respiratory disease, cerebrovascular disease, intracranial HTN (including glaucoma), or seizures
  • Presence of foreign body (including pacemaker)
  • Pregnancy
  • Allergies to anesthetics used in study Includes: a) Ketamine b) Propofol c) Eggs d) Egg products e) Soybeans f) Soy products
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01935115
UofSKetamine-01
Yes
Not Provided
Plan to Share IPD: No
Jonathan Gamble, University of Saskatchewan
University of Saskatchewan
  • Saskatoon Health Region
  • Royal University Hospital Foundation
  • Schulman Research Award
Principal Investigator: Jonathan Gamble, MD University of Saskatchewan
University of Saskatchewan
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP