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Ketamine Anesthesia in Electroconvulsive Therapy

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ClinicalTrials.gov Identifier: NCT01367119
Recruitment Status : Completed
First Posted : June 6, 2011
Results First Posted : August 6, 2013
Last Update Posted : August 8, 2013
Sponsor:
Information provided by:
Mayo Clinic

Tracking Information
First Submitted Date  ICMJE June 1, 2011
First Posted Date  ICMJE June 6, 2011
Results First Submitted Date  ICMJE March 18, 2013
Results First Posted Date  ICMJE August 6, 2013
Last Update Posted Date August 8, 2013
Study Start Date  ICMJE May 2011
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2013)
Mean Depression Rating Using the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline and after every second treatment for 7 treatments ]
The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 42 (severe symptoms) for either anxiety or depression. The questionnaire was administered to the subjects prior to the first treatment, the morning of the third treatment, the morning of the fifth treatment, and the morning of the seventh treatment. For subjects whose treatment series ws cancelled prior to a scheduled next administration of the rating scale, every effort was made to administer them 2 days after the last treatment. Means are reported overall across all treatments; p-values also take into account variability across treatments and within subject.
Original Primary Outcome Measures  ICMJE
 (submitted: June 3, 2011)
depression ratings using the Hospital Anxiety and Depression Scale [ Time Frame: Baseline and after every second treatment for 20 mins. ]
Patients will be followed with these outcome measures as long as they are still receiving inpatient ECT treatments. The number of treatments will be determined entirely by their primary psychiatric team, also blind to anesthetic, as per usual care. In other words, this study will not be determining when to terminate the ECT course.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2013)
  • Mean Depression Rating Using the Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline and after every second treatment for 7 treatments ]
    The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 27 (severe symptoms) for depression. The questionnaire was administered to the subjects prior to the first treatment, the morning of the third treatment, the morning of the fifth treatment, and the morning of the seventh treatment. For subjects whos treatment series ws cancelled prior to a scheduled next administration of the rating scale, every effort was mde to administer them 2 days after the last treatment. Means are reported overall across all treatments; p-values also take into account variability across treatments and within subject.
  • Mean Post Anesthesia Recovery Side Effects [ Time Frame: Time of discharge from recovery after ECT for each treatment, approximately 30 minutes after the end of the seizure ]
    Post anesthesia recovery side effects were assessed at the time of discharge from recovery with five patient self-report items: nausea, headache, myalgia, visual disturbance, and confusion. These were rated by the patients on a four point scale (0, 1, 2, 3) - absent, mild, moderate, severe. This means that for each item a subject could score between 0 (no symptoms) and 3 (severe symptoms). Also, degree of recovery room agitation was rated by the nurse on a similar four point scale.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Anesthesia in Electroconvulsive Therapy
Official Title  ICMJE A Randomized Comparison of Ketamine and Methohexital Anesthesia for Electroconvulsive Therapy (ECT) in Depression
Brief Summary

Does the use of ketamine as the anesthetic medication in electroconvulsive therapy (ECT) accelerate the antidepressant effect of ECT?

The study hypothesis was that depressed subjects receiving ECT with ketamine as the anesthetic agent would demonstrate a faster rate of improvement, defined as lower depression ratings after the second ECT than depressed patients receiving ECT with the usual anesthetic agent.

Detailed Description

There are several drugs available to induce anesthesia for electroconvulsive therapy (ECT), a psychiatric treatment for major depressive illness. The most commonly utilized of these include methohexital, thiopental, etomidate, and propofol. Recently, there has been interest in the use of ketamine in sub-anesthetic doses to treat major depressive illness.

In this randomized, blinded trial, depressed subjects scheduled to be treated with ECT were anesthetized with either ketamine or methohexital at doses of approximately 1.0 mg/kg for each drug. Patients received the same drug for up to six of their ECT treatments. Outcome measures included assessments of depressive severity, cognition, post-anesthesia side effects, and hemodynamics.

Subjects were to be followed with as long as they were receiving inpatient ECT treatments. The number of treatments was determined entirely by their primary psychiatric team, also blind to anesthetic, as per usual care. In other words, this study did not determine when to terminate the ECT course.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • Drug: Ketamine
    Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic.
    Other Names:
    • Ketalar
    • Ketamine Hydrocholoride
  • Drug: methohexital
    Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic.
    Other Name: Brevital Sodium
Study Arms  ICMJE
  • Active Comparator: Ketamine
    Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
    Intervention: Drug: Ketamine
  • Active Comparator: Methohexital
    Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
    Intervention: Drug: methohexital
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 3, 2013)
38
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2011)
34
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Diagnosis of depression, either unipolar or bipolar
  • Subjects receiving ECT at the Mayo Clinic

Exclusion criteria:

  • Subjects not giving their own consent to ECT
  • Subjects with schizophrenia, schizoaffective disorder, or dementia
  • Subjects diagnosed with a major neurological disorder such as epilepsy, Parkinson disease, multiple sclerosis, or a neurodegenerative dementia.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01367119
Other Study ID Numbers  ICMJE 11-001430
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Keith Rasmussen, MD, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Keith Rasmussen, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date August 2013

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