Ketamine Anesthesia for Improvement of Depression in ECT
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 6/7/2018 |
| Start Date: | March 2016 |
| End Date: | April 30, 2018 |
Ketamine vs. Methohexital Anesthesia for Improvement of Major Depressive Disorder in Electroconvulsive Therapy
The purpose of this prospective randomized clinical trial is to determine if patients
receiving ketamine as a part of general anesthesia during electroconvulsive therapy (ECT)
rather than standard of care will have improvement in symptoms of depression after a course
of ECT treatments. The investigators hypothesize that utilization of ketamine for induction
of general anesthesia during ECT treatments will improve symptoms of depression better than
standard care.
This study is ONLY open to patients eligible to receive healthcare services through the
Department of Veterans Affairs at the VA Puget Sound, which means service in the active
military, naval or air service or separation under any condition other than dishonorable.
Qualifications for VA health care benefits can be found at va.gov.
receiving ketamine as a part of general anesthesia during electroconvulsive therapy (ECT)
rather than standard of care will have improvement in symptoms of depression after a course
of ECT treatments. The investigators hypothesize that utilization of ketamine for induction
of general anesthesia during ECT treatments will improve symptoms of depression better than
standard care.
This study is ONLY open to patients eligible to receive healthcare services through the
Department of Veterans Affairs at the VA Puget Sound, which means service in the active
military, naval or air service or separation under any condition other than dishonorable.
Qualifications for VA health care benefits can be found at va.gov.
The purpose of this prospective randomized clinical trial is to determine if patients
receiving ketamine as a part of general anesthesia during electroconvulsive therapy (ECT)
rather than standard of care will have improvement in symptoms of depression after a course
of ECT treatments. The investigators hypothesize that utilization of ketamine for induction
of general anesthesia during ECT treatments will improve symptoms of depression better than
standard care.
For induction of general anesthesia for ECT, patients will receive either 1mg/kg of
methohexital (standard arm) or 1.0 mg/kg IV ketamine (experimental arm) intravenously (IV)
for the duration of their ECT index course over 2-3 weeks. The primary outcome in this trial
is change in symptoms of depression assessed by standard questionnaires: Patient Health
Questionnaire 9 (PHQ9) and Hamilton Depression Rating Scale (HAM-D) score changes from
baseline and final ECT administration. Secondary outcomes are changes in cognitive status as
assessed by the Montreal Cognitive Assessment (MoCA) scale, quality of seizures and after
seizure, changes in serum metabolites (including kynurenine, D/L-serine and other glutamate
intermediates) after treatment and need for further ECT courses (relapse) within 1 year after
initial course.
Approximately 50 veterans with the diagnosis of major depressive disorder older than 18 years
of age undergoing ECT will be randomized and blinded to the intervention. Operative ECT
clinicians will not be blinded; clinicians evaluating patients will be blinded. Exclusion
criteria for this study include uncontrolled hypertension, blood pressure > 180/90 mmHg at
the pre-anesthesia clinic visit, renal failure, neurologic disorders (e.g. epilepsy, space
occupying lesions, traumatic brain injuries in the past 6 months), myocardial infarction in
the past 6 months, known allergies or adverse reactions to ketamine, American Society of
Anesthesiology Physical Class greater than 3, concomitant psychosis, schizophrenia or current
abuse of alcohol or illicit substances and pregnancy.
The long term objective of this trial is to systematically characterize ketamine's effect on
depression outcomes utilizing validated scoring tools, its safety profile throughout an ECT
index course, ketamine's effect on seizure quality and changes in novel translational
endpoints to better understand mechanisms of action of ketamine and its potential role in
treatment of psychiatric disorders.
receiving ketamine as a part of general anesthesia during electroconvulsive therapy (ECT)
rather than standard of care will have improvement in symptoms of depression after a course
of ECT treatments. The investigators hypothesize that utilization of ketamine for induction
of general anesthesia during ECT treatments will improve symptoms of depression better than
standard care.
For induction of general anesthesia for ECT, patients will receive either 1mg/kg of
methohexital (standard arm) or 1.0 mg/kg IV ketamine (experimental arm) intravenously (IV)
for the duration of their ECT index course over 2-3 weeks. The primary outcome in this trial
is change in symptoms of depression assessed by standard questionnaires: Patient Health
Questionnaire 9 (PHQ9) and Hamilton Depression Rating Scale (HAM-D) score changes from
baseline and final ECT administration. Secondary outcomes are changes in cognitive status as
assessed by the Montreal Cognitive Assessment (MoCA) scale, quality of seizures and after
seizure, changes in serum metabolites (including kynurenine, D/L-serine and other glutamate
intermediates) after treatment and need for further ECT courses (relapse) within 1 year after
initial course.
Approximately 50 veterans with the diagnosis of major depressive disorder older than 18 years
of age undergoing ECT will be randomized and blinded to the intervention. Operative ECT
clinicians will not be blinded; clinicians evaluating patients will be blinded. Exclusion
criteria for this study include uncontrolled hypertension, blood pressure > 180/90 mmHg at
the pre-anesthesia clinic visit, renal failure, neurologic disorders (e.g. epilepsy, space
occupying lesions, traumatic brain injuries in the past 6 months), myocardial infarction in
the past 6 months, known allergies or adverse reactions to ketamine, American Society of
Anesthesiology Physical Class greater than 3, concomitant psychosis, schizophrenia or current
abuse of alcohol or illicit substances and pregnancy.
The long term objective of this trial is to systematically characterize ketamine's effect on
depression outcomes utilizing validated scoring tools, its safety profile throughout an ECT
index course, ketamine's effect on seizure quality and changes in novel translational
endpoints to better understand mechanisms of action of ketamine and its potential role in
treatment of psychiatric disorders.
Inclusion Criteria:
- outpatients or inpatients at the Puget Sound VA with diagnosis of major depressive
disorder or bipolar 1 or 2 over the age of 18 undergoing index course ECT
Exclusion Criteria:
- uncontrolled hypertension (blood pressure > 180/90 mmHg at the pre-anesthesia clinic
visit)
- renal failure
- neurologic disorders (e.g. epilepsy, space occupying lesions, traumatic brain injuries
in the past 6 months)
- myocardial infarction in the past 6 months
- known allergies or adverse reactions to ketamine
- American Society of Anesthesiology Physical Class greater than 3
- concomitant psychosis
- schizophrenia or current abuse of alcohol or illicit substances and pregnancy (any
trimester)
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