EEG Characteristics in ECT

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-10-01

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.

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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.

Conditions

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Electroconvulsive Therapy Direct Current Electroencephalogram Ketamine Spreadind Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Methohexital

Standard of care anesthesia that does not affect slow wave characteristics

Group Type ACTIVE_COMPARATOR

Methohexital

Intervention Type DRUG

Induction agent that does not suppress infra-slow waves

Ketamine

Standard of care anesthesia that suppresses slow wave characteristics

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Induction agent that suppresses infra-slow waves

Interventions

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Ketamine

Induction agent that suppresses infra-slow waves

Intervention Type DRUG

Methohexital

Induction agent that does not suppress infra-slow waves

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No