Comparing Ketamine and Propofol Anesthesia for Electroconvulsive Therapy
Recruitment status was Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Prospective Randomized Double Blinded Control Trial Using Ketamine or Propofol Anesthesia for Electroconvulsive Therapy: Improving Treatment-Resistant Depression|
- 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 ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Propofol
The control group will receive propofol 1 mg/kg
Propofol anesthesia for ECT
Other Name: Diprivan
Study group will receive ketamine 0.75 mg/kg intravenously
Ketamine anesthesia for ECT
Other Name: Ketalar
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01935115
|Contact: Jonathan Gamble, MD||1-306-655-1183||J_Gamble@yahoo.com|
|Contact: Rudy Bowen, MD||1-306-966-8223||R.Bowen@usask.ca|
|Royal University Hospital||Recruiting|
|Saskatoon, Saskatchewan, Canada, S7N 0W8|
|Principal Investigator: Jonathan Gamble, MD|
|Principal Investigator:||Jonathan Gamble, MD||University of Saskatchewan|