Ketamine Anesthesia in Electroconvulsive Therapy

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01367119
First received: June 1, 2011
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Depression
Drug: Ketamine
Drug: methohexital

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Ketamine and Methohexital Anesthesia for Electroconvulsive Therapy (ECT) in Depression

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Mean Depression Rating Using the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline and after every second treatment for 7 treatments ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Mean Depression Rating Using the Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline and after every second treatment for 7 treatments ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 38
Study Start Date: May 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ketamine
Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
Drug: Ketamine
Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic.
Other Names:
  • Ketalar
  • Ketamine Hydrocholoride
Active Comparator: Methohexital
Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
Drug: methohexital
Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic.
Other Name: Brevital Sodium

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367119

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Keith Rasmussen, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Keith Rasmussen, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01367119     History of Changes
Other Study ID Numbers: 11-001430
Study First Received: June 1, 2011
Results First Received: March 18, 2013
Last Updated: August 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Depression
Electroconvulsive therapy
Ketamine
Methohexital

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ketamine
Anesthetics
Methohexital
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014