Ketamine Anesthesia in Electroconvulsive Therapy

• 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: Mayo Clinic
• Information provided by: Mayo Clinic

Tracking Information

• First Submitted Date: June 1, 2011
• First Posted Date: June 6, 2011
• Results First Submitted Date: March 18, 2013
• Results First Posted Date: August 6, 2013
• Last Update Posted Date: August 8, 2013
• Study Start Date: May 2011
• Actual Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ketamine Anesthesia in Electroconvulsive Therapy
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Depression

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 3, 2013): 38
• Original Estimated Enrollment (submitted: June 3, 2011): 34
• Actual Study Completion Date: March 2012
• Actual Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01367119
• Other Study ID Numbers: 11-001430
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Keith Rasmussen, MD, Mayo Clinic
• Original Responsible Party: Same as current
• Current Study Sponsor: Mayo Clinic
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Keith Rasmussen, MD; Mayo Clinic

• PRS Account: Mayo Clinic
• Verification Date: August 2013