CET- REM (Correlating ECT Response to EEG Markers)

The Washington University

Status: Active, not recruiting

Conditions: Treatment Resistant Depression; ECT

Treatments: Diagnostic Test: Ictal Electroencephalographic (EEG) Measurements; Diagnostic Test: Post-Ictal Electroencephalographic (EEG) Suppression Measurements; Diagnostic Test: Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16); Diagnostic Test: Electroencephalographic (EEG)

Study type: Interventional

Funder types: Other

Identifiers

NCT04451135

202006108

Details and patient eligibility

About

Single-center study to determine the relationship between changes in depression symptoms and electroencephalographic (EEG) patterns induced by electroconvulsive therapy (ECT)

Full description

Electroconvulsive therapy (ECT) is an effective treatment for many psychiatric illnesses, including major depressive disorder. While effective, objective markers have not been developed to predict clinical outcome trajectories following ECT. This is important given the risks and costs incurred during a full treatment course. Electroencephalography (EEG) is typically employed to monitor the generation and termination of ECT-induced seizures but leverage of markers toward prognostication remains a future goal. The investigators have characterized two distinct EEG patterns associated with ECT-induced generalized seizures and have two sleep markers that may serve as markers for predicting response to treatment. Central Positive Complexes (CPCs) are large ictal complexes with a scalp topology of voltage declining from the top of the head. CPCs are localized to cortical areas that are involved in the formation of sleep spindles and slow wave sleep. A pattern of low-voltage activity, known as post-ictal generalized electroencephalographic suppression (PGES), is frequently used to document termination of these seizures. Additionally, two EEG markers of sleep microstructure may have utility given their association with synaptic plasticity, a process presumably invoked over the course of ECT-induced recovery from psychiatric illness as pathologic neural circuitry undergoes reconfiguration. These two markers, sleep spindles and slow waves show altered expression patterns in patients with psychiatric disorders, and thus may be useful as objective markers of ECT responsiveness. None of the above EEG markers have been explored for an association to interval changes in disease severity over the course of ECT. This project will incisively probe the relationships between temporal trajectories of major depressive disorder severity and longitudinal measurements of ictal and postictal EEG markers.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or greater
• Referral for ECT index course for treatment-resistant depression (unipolar major depressive disorder or bipolar depression), major depressive disorder with psychotic symptoms, schizophrenia or schizoaffective being treated for a depressed episode, unspecified depression

Exclusion criteria

• Schizophrenia or schizoaffective disorder not being treated for a depressed episode.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Patients with Treatment-Resistant Depression

Experimental group

Treatment:

Diagnostic Test: Electroencephalographic (EEG)

Diagnostic Test: Post-Ictal Electroencephalographic (EEG) Suppression Measurements

Diagnostic Test: Ictal Electroencephalographic (EEG) Measurements

Diagnostic Test: Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16)