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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine | Active Comparator | Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT). |
|
| Methohexital | Active Comparator | Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and after every second treatment for 7 treatments |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith Rasmussen, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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Subjects were enrolled at Mayo Clinic, Rochester, Minnesota.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine | Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT). |
| FG001 | Methohexital | Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine | Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT). |
| BG001 | Methohexital | Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis was intent to treat; for the ketamine arm there were 54 observations, for the methohexital arm there were 55 observations. | Posted | Mean | Standard Deviation | units on a scale | Baseline and after every second treatment for 7 treatments |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketamine | Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Keith G. Rassmussen | Mayo Clinic | 507-284-2933 | rasmussen.keith@mayo.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D008723 | Methohexital |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| methohexital | Drug | Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic. |
|
|
| Baseline and after every second treatment for 7 treatments |
| 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. | Time of discharge from recovery after ECT for each treatment, approximately 30 minutes after the end of the seizure |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Ketamine | Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT). |
| OG001 | Methohexital | Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy. |
|
|
|
| Secondary | 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. | Analysis was intent to treat; for the ketamine arm there were 65 observations, for the methohexital arm there were 63 observations. | Posted | Mean | Standard Deviation | units on a scale | Baseline and after every second treatment for 7 treatments |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Time of discharge from recovery after ECT for each treatment, approximately 30 minutes after the end of the seizure |
|
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Methohexital | Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy. | 0 | 17 | 0 | 17 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001463 | Barbiturates |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Myalgia |
|
| Visual Disturbance |
|
| Confusion |
|
| Recovery Room Agitation |
|
| 0.763 |
| 95 |
| No |
| Superiority or Other |
| Comparison between groups for myalgia | t-test, 2 sided | 0.356 | 95 | No | Superiority or Other |
| Comparison between groups for visual disturbance | t-test, 2 sided | 0.093 | 95 | No | Superiority or Other |
| Comparison between groups for confusion | t-test, 2 sided | 0.003 | 95 | No | Superiority or Other |
| Comparison between groups for recovery room agitation | t-test, 2 sided | 0.860 | 95 | No | Superiority or Other |