Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ketamine Anesthesia in Electroconvulsive Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depression
Interventions Drug: Ketamine
Drug: methohexital
Enrollment 38
Recruitment Details Subjects were enrolled at Mayo Clinic, Rochester, Minnesota.
Pre-assignment Details  
Arm/Group Title Ketamine Methohexital
Hide Arm/Group 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.
Period Title: Overall Study
Started 21 17
Completed 19 16
Not Completed 2 1
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             1             1
Arm/Group Title Ketamine Methohexital Total
Hide Arm/Group 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. Total of all reporting groups
Overall Number of Baseline Participants 21 17 38
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 17 participants 38 participants
46.95  (13.17) 48.65  (7.20) 47.7  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 17 participants 38 participants
Female
16
  76.2%
8
  47.1%
24
  63.2%
Male
5
  23.8%
9
  52.9%
14
  36.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 17 participants 38 participants
21 17 38
1.Primary Outcome
Title Mean Depression Rating Using the Hospital Anxiety and Depression Scale (HADS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent to treat; for the ketamine arm there were 54 observations, for the methohexital arm there were 55 observations.
Arm/Group Title Ketamine Methohexital
Hide Arm/Group 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.
Overall Number of Participants Analyzed 21 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
22.08  (8.11) 24.45  (7.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine, Methohexital
Comments P-values take into account variability across treatments and within subject.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.171
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Mean Depression Rating Using the Patient Health Questionnaire-9 (PHQ-9)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent to treat; for the ketamine arm there were 65 observations, for the methohexital arm there were 63 observations.
Arm/Group Title Ketamine Methohexital
Hide Arm/Group 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.
Overall Number of Participants Analyzed 21 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
15.98  (7.54) 17.57  (6.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine, Methohexital
Comments P-values take into account variability across treatments and within subject.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.258
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Mean Post Anesthesia Recovery Side Effects
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Methohexital
Hide Arm/Group 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.
Overall Number of Participants Analyzed 21 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Nausea 0.12  (0.39) 0.15  (0.42)
Headache 0.29  (0.61) 0.35  (0.67)
Myalgia 0.07  (0.30) 0.15  (0.48)
Visual Disturbance 0.08  (0.28) 0.01  (0.11)
Confusion 0.70  (0.95) 0.30  (0.53)
Recovery Room Agitation 0.07  (0.26) 0.09  (0.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine, Methohexital
Comments Comparison between groups for nausea
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.091
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ketamine, Methohexital
Comments Comparison between groups for headache
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.763
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ketamine, Methohexital
Comments Comparison between groups for myalgia
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.356
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ketamine, Methohexital
Comments Comparison between groups for visual disturbance
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.093
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ketamine, Methohexital
Comments Comparison between groups for confusion
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ketamine, Methohexital
Comments Comparison between groups for recovery room agitation
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.860
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Methohexital
Hide Arm/Group 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.
All-Cause Mortality
Ketamine Methohexital
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ketamine Methohexital
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ketamine Methohexital
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/17 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Keith G. Rassmussen
Organization: Mayo Clinic
Phone: 507-284-2933
Responsible Party: Keith Rasmussen, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01367119     History of Changes
Other Study ID Numbers: 11-001430
First Submitted: June 1, 2011
First Posted: June 6, 2011
Results First Submitted: March 18, 2013
Results First Posted: August 6, 2013
Last Update Posted: August 8, 2013