EEG Characteristics in ECT

A Randomized Pilot Study Examining DCEEG Characteristics in Ketamine Versus Methohexital Induction in Depressed Patients Receiving Electroconvulsive Therapy

The investigators will be examining slow-wave characteristics in depressed patients receiving electroconvulsive therapy (ECT) using direct current electroencephalogram (dcEEG) by anesthesia induction agent.

Study Overview

• Status: Completed
• Conditions: Ketamine; Electroconvulsive Therapy; Direct Current Electroencephalogram; Spreadind Depression
• Intervention / Treatment: Drug: Methohexital; Drug: Ketamine

Detailed Description

This is a pilot project using dcEEG to look at infra-slow waves in depressed patients receiving ECT randomized to ketamine or methohexital where ketamine suppresses infra-slow waves. The rationale for this project is to identify biomarkers of treatment adequacy in ECT, which could lead to decreased morbidity and mortality with the procedure and lessen the burden of depression in our patient population.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Structured Clinical Interview for DSM-5 will confirm diagnosis of MDD or BPD-depressed (with or without psychotic features
• The clinical indications for ECT including treatment resistance or a need for a rapid and definitive response;
• Hamilton Depression Rating Scale 24-item (HDRS-24) > 21; and
• Age range between 18 and 65 years of age.

Exclusion Criteria:

• Defined neurological or neurodegenerative disorder (e.g., history of head injury with loss of consciousness > 5 minutes, epilepsy, Alzheimer's disease);
• Other psychiatric conditions (e.g., schizophrenia, schizoaffective disorder, bipolar disorder)
• Current drug or alcohol use disorder, except for nicotine and marijuana
• Adults unable to consent, pregnant women, prisoner
• Non-English speakers
• Patients that cannot tolerate Methohexital and Ketamine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Methohexital; Standard of care anesthesia that does not affect slow wave characteristics	Drug: Methohexital; Induction agent that does not suppress infra-slow waves
Experimental: Ketamine; Standard of care anesthesia that suppresses slow wave characteristics	Drug: Ketamine; Induction agent that suppresses infra-slow waves

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Efficacy of ECT	Quick Inventory of Depressive Symptomatology (QIDS) and Self Reporting version (QIDS-SR) - Range 0 - 48 with higher number indicating worsening depression.	Outcome measures will be assessed the first, second, middle, and final ECT treatment over the course of 1 month on average for each patient. Data will be reported at 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive performance	Montreal Cognitive Assessment. Measures global cognitive function. 0-30 with higher score indicates better cognitive function; Dot Counting Test measures effort. Time to completion and errors recorded. Higher times/error rates indicate decreased effort; Test of Premorbid Function estimates premorbid intellectual function. Negative change indicates greater cognitive & memory function impairment; Autobiographical Memory Test. Free recall of retrospective autobiographical memories. 0-20 with higher score indicating improved memory function; Hopkins Verbal Learning Test-Revised. Free recall, and recognition memory. Retention % calculated. Higher percentage indicates improved cognitive function; Delis Kaplan Executive Function System Color-Word Interference & Verbal Fluency Test. Processing speed, sequencing and cognitive flexibility This neuropsychological battery will be used to compute composite z-scores that represent global cognitive function at each time point	Outcome measures assessed at first, second, middle, and final ECT treatment over the course of 1 month on average for each patient. Data will be reported at 1 year.
Direct current electroencephalogram slow wave phenomenon (exploratory outcome)	Analysis will assess magnitude of slow-wave phenomena (area under the curve in cm^2)	dcEEG data will be collected the first, second, middle, and final ECT treatment over the course of 1 month on average for each patient. Data will be reported at 1 year.
ECT parameters and their correlation to production of slow-wave phenomenon	Analysis will correlate electrode placement and pulse width with production of slow-waves on dcEEG.	This will be assessed throughout the year.

Collaborators and Investigators

• Sponsor: University of New Mexico

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine; Methohexital
• Other Study ID Numbers: 19-228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: An embargo of 2 years will be placed on the data after Master's Thesis is published and placed into the vault to allow for publications. Afterwards, it will be available as along as the vault is maintained.
• IPD Sharing Access Criteria: Pilot project is being done as a part of a Master's Thesis which will be uploaded to the University of New Mexico digital repository and may contain supporting information as above.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No