EEG Characteristics in ECT

Early Phase 1CompletedNCT04022226

University of New Mexico11 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Electroconvulsive Therapy Direct Current Electroencephalogram Ketamine Spreadind Depression

Interventions

KetamineDRUG

Induction agent that suppresses infra-slow waves

MethohexitalDRUG

Induction agent that does not suppress infra-slow waves

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of New Mexico Mental Health Center

Albuquerque, New Mexico, United States

Outcomes

Primary Outcomes

Number of Participants Assessed for 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. Inadequate sample size due to COVID. Study was closed.

Time frame: 1 year

Data from ClinicalTrials.gov

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