EEG Characteristics in ECT

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

Detailed Description
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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.

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

Conditions
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Electroconvulsive Therapy, Direct Current Electroencephalogram, Ketamine, Spreadind Depression

Intervention / Treatment
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* Drug: Ketamine
* Drug: Methohexital


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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. |