Major Depressive Disorder Clinical Trial
— KAIDOfficial title:
Ketamine vs. Methohexital Anesthesia for Improvement of Major Depressive Disorder in Electroconvulsive Therapy
NCT number | NCT02752724 |
Other study ID # | 00850 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | April 30, 2018 |
Verified date | June 2018 |
Source | VA Puget Sound Health Care System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | April 30, 2018 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | VA Puget Sound Health Care System | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
VA Puget Sound Health Care System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Depression Patient Health Questionnaire 9 (PHQ9) Scoring | 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. | Change from Baseline Score 24 hours prior to starting ECT to PHQ9 score 72 hours following last ECT session | |
Secondary | Soluble Amino Acid Metabolomic Biomarkers | 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. | 30 minutes prior to first ECT session and within 30 minutes after final ECT session | |
Secondary | ECT Seizure Duration | 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. | 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. | |
Secondary | Change in Montreal Cognitive Assessment (MoCA) Scoring | 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. | Change from Baseline Score 24 hours prior to starting ECT to MoCA score 72 hours following last ECT session |
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