Ketamine Anesthesia for Improvement of Depression in ECT

NCT02752724 | Completed DMC

• 1 other identifier: 00850
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

major depressive disorder; electroconvulsive therapy; metabolomics; treatment resistant depression; anesthesiology; ketamine; prospective randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Soluble Amino Acid Metabolomic Biomarkers

  30 minutes prior to first ECT session and within 30 minutes after final ECT session

• ECT Seizure Duration

  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.

• Change in Montreal Cognitive Assessment (MoCA) Scoring

  Change from Baseline Score 24 hours prior to starting ECT to MoCA score 72 hours following last ECT session

Study Arms (2)

Ketamine Interventional Arm

EXPERIMENTAL

1.0 mg/kg IV ketamine (experimental arm) intravenously (IV) for the duration of their ECT index course over 2-3 weeks

Drug: Ketamine

Methohexital Control Arm

ACTIVE COMPARATOR

1mg/kg of methohexital (standard arm) intravenously (IV) for the duration of their ECT index course over 2-3 weeks

Drug: Methohexital

Interventions

Ketamine DRUG

Ketamine anesthesia for ECT index course with measurement cerebral metabolic regional oximetry, EEG seizure quality, cognitive scoring and serum metabolites.

Also known as: Ketalar

Ketamine Interventional Arm

Methohexital DRUG

Methohexital anesthesia for ECT index course with measurement cerebral metabolic regional oximetry, EEG seizure quality, cognitive scoring and serum metabolites.

Also known as: Brevital

Methohexital Control Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Puget Sound Health Care System: lead

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant

Interventions

Ketamine; Methohexital

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Anna Borisovskaya, MD

  Puget Sound VA Medical Center, Dept of Psychiatry

  STUDY DIRECTOR

• Irene Rozet, MD

  Puget Sound VA Medical Center, Dept of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician --Anesthesiologist

Study Record Dates

• First Submitted: March 25, 2016
• First Posted: April 27, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 30, 2018
• Last Updated: June 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)