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Ketamine Anesthesia for Improvement of Depression in ECT (KAID)

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ClinicalTrials.gov Identifier: NCT02752724
Recruitment Status : Completed
First Posted : April 27, 2016
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Charles William Carspecken, MD, MBA, MSc, VA Puget Sound Health Care System

Tracking Information
First Submitted Date  ICMJE March 25, 2016
First Posted Date  ICMJE April 27, 2016
Last Update Posted Date June 5, 2018
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2016)
Change in Depression Patient Health Questionnaire 9 (PHQ9) Scoring [ Time Frame: Change from Baseline Score 24 hours prior to starting ECT to PHQ9 score 72 hours following last ECT session ]
Evaluate the efficacy and safety of repeat anesthetic ketamine dosing during a complete index course of ECT compared with methohexital using change in a validated depression scoring tool (Patient Health Questionnaire 9) administered 24 hours prior to starting an ECT index course treatment (baseline) with a PHQ9 score 72 hours after the last/final ECT session for approximately fifty patients. The PHQ9 Scoring ranges from 0 to 27 in order to monitor depression severity over time for newly diagnosed patients or patients in current treatment for depression.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02752724 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2018)
  • Soluble Amino Acid Metabolomic Biomarkers [ Time Frame: 30 minutes prior to first ECT session and within 30 minutes after final ECT session ]
    Measurement of biomarkers before/after ECT index course serum aqueous metabolites from patient venous blood drawn from intravenous line specifically concentration of serine, tryptophan, quinolinic acid, kynurenine in mcg/dL using mass spectrometry. Samples are collected 30 minutes prior to first ECT session and within 30 minutes after final ECT treatment session.
  • ECT Seizure Duration [ Time Frame: Length of each intraoperative ECT seizure during an index course typically 6-12 individual seizures measure from start of seizure in operating room to end of seizure in operating room. ]
    This trial will measure intra-operative seizure length/duration (in seconds) using a standard ECT machine which helps the ECT machine operator determine the total length of time a patient is seizing during each ECT seizure session. An index course of ECT treatment typically involves 6 to 12 seizures titrated to a patient's response. The investigators will record the length of seizure for every treatment session for every patient.
  • Change in Montreal Cognitive Assessment (MoCA) Scoring [ Time Frame: Change from Baseline Score 24 hours prior to starting ECT to MoCA score 72 hours following last ECT session ]
    Evaluate the efficacy and safety of repeat anesthetic ketamine dosing during a complete index course of ECT compared with methohexital using change in a validated cognitive scoring tool (Montreal Cognitive Assessment MoCA) administered 24 hours prior to starting an ECT index course treatment (baseline) with a MoCA score 72 hours after the last/final ECT session for approximately fifty patients. The MoCA Scoring ranges from 0 to 30 in order to rapidly screen for mild cognitive dysfunction.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2016)
  • Soluble Amino Acid Metabolomic Biomarkers [ Time Frame: 30 minutes prior to first ECT session and within 30 minutes after final ECT session ]
    Measurement of biomarkers before/after ECT index course serum aqueous metabolites from patient venous blood drawn from intravenous line specifically concentration of serine, tryptophan, quinolinic acid, kynurenine in mcg/dL using mass spectrometry. Samples are collected 30 minutes prior to first ECT session and within 30 minutes after final ECT treatment session.
  • EEG Seizure 2 Lead Tracing Measurements During Seizure [ Time Frame: EEG tracing at each of 6-12 index course ECT sessions over 2-3 weeks ]
    Intraoperative measurement of seizure quality using ECT machine 2 lead system printout during and after each of 6-12 ECT sessions. These tracings are printed regardless of patient trial enrollment and will be scored for quality using validated techniques for seizure duration (in seconds), amplitude (in microVolts) and synchronicity (in percentage of seizure duration two hemispheres are synchronous over total seizure time)..
  • Regional Cerebral Oximetry Changes During and After Seizure [ Time Frame: Measurements of regional cerebral oximetry during the perioperative course of the first and last/final ECT session (approx 3 weeks after first treatment session) ]
    The investigators will examine the changes in non-invasive near-infrared spectroscopy (measured in percentage oxygenation out of 100) during the first and last ECT index course seizure sessions. The recordings will made continuously before induction, during seizure and during the post-ictal period every 4 seconds and extracted from the Nonin Regional Oximetry Device. These measurements will be taken during the first ECT index course seizure and the last/final seizure in the index course typically 3 weeks after the first treatment.
  • Change in Montreal Cognitive Assessment (MoCA) Scoring [ Time Frame: Change from Baseline Score 24 hours prior to starting ECT to MoCA score 72 hours following last ECT session ]
    Evaluate the efficacy and safety of repeat anesthetic ketamine dosing during a complete index course of ECT compared with methohexital using change in a validated cognitive scoring tool (Montreal Cognitive Assessment MoCA) administered 24 hours prior to starting an ECT index course treatment (baseline) with a MoCA score 72 hours after the last/final ECT session for approximately fifty patients. The MoCA Scoring ranges from 0 to 30 in order to rapidly screen for mild cognitive dysfunction.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Anesthesia for Improvement of Depression in ECT
Official Title  ICMJE Ketamine vs. Methohexital Anesthesia for Improvement of Major Depressive Disorder in Electroconvulsive Therapy
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Ketamine
    Ketamine anesthesia for ECT index course with measurement cerebral metabolic regional oximetry, EEG seizure quality, cognitive scoring and serum metabolites.
    Other Name: Ketalar
  • Drug: Methohexital
    Methohexital anesthesia for ECT index course with measurement cerebral metabolic regional oximetry, EEG seizure quality, cognitive scoring and serum metabolites.
    Other Name: Brevital
Study Arms  ICMJE
  • Experimental: Ketamine Interventional Arm
    1.0 mg/kg IV ketamine (experimental arm) intravenously (IV) for the duration of their ECT index course over 2-3 weeks
    Intervention: Drug: Ketamine
  • Active Comparator: Methohexital Control Arm
    1mg/kg of methohexital (standard arm) intravenously (IV) for the duration of their ECT index course over 2-3 weeks
    Intervention: Drug: Methohexital
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 1, 2018)
52
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2016)
50
Actual Study Completion Date  ICMJE April 30, 2018
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02752724
Other Study ID Numbers  ICMJE 00850
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Charles William Carspecken, MD, MBA, MSc, VA Puget Sound Health Care System
Study Sponsor  ICMJE VA Puget Sound Health Care System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Anna Borisovskaya, MD Puget Sound VA Medical Center, Dept of Psychiatry
Principal Investigator: Irene Rozet, MD Puget Sound VA Medical Center, Dept of Anesthesiology
PRS Account VA Puget Sound Health Care System
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP