Ketamine Anesthesia in Electroconvulsive Therapy
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketamine
methohexital
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Electroconvulsive therapy, Ketamine, Methohexital
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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ketamine
Methohexital
Arm Description
Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
Outcomes
Primary Outcome Measures
Mean Depression Rating Using the Hospital Anxiety and Depression Scale (HADS)
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)
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01367119
Brief Title
Ketamine Anesthesia in Electroconvulsive Therapy
Official Title
A Randomized Comparison of Ketamine and Methohexital Anesthesia for Electroconvulsive Therapy (ECT) in Depression
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Electroconvulsive therapy, Ketamine, Methohexital
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketamine
Arm Type
Active Comparator
Arm Description
Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
Arm Title
Methohexital
Arm Type
Active Comparator
Arm Description
Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketalar, Ketamine Hydrocholoride
Intervention Description
Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic.
Intervention Type
Drug
Intervention Name(s)
methohexital
Other Intervention Name(s)
Brevital Sodium
Intervention Description
Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic.
Primary Outcome Measure Information:
Title
Mean Depression Rating Using the Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
Baseline and after every second treatment for 7 treatments
Secondary Outcome Measure Information:
Title
Mean Depression Rating Using the Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
Baseline and after every second treatment for 7 treatments
Title
Mean Post Anesthesia Recovery Side Effects
Description
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.
Time Frame
Time of discharge from recovery after ECT for each treatment, approximately 30 minutes after the end of the seizure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Rasmussen, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ketamine Anesthesia in Electroconvulsive Therapy
We'll reach out to this number within 24 hrs