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NCT Number: NCT04451135

CET- REM (Correlating ECT Response to EEG Markers)

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

ECT Depressive Disorder Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders Treatment Resistant Depression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electroencephalographic (EEG)

Diagnostic Test

EEG on nights after ECT session will be recorded using the DREEM device. Sleep EEG data will also be acquired for a minimum of one night prior to the first ECT session, providing a true baseline measure. The DREEM device allows continuous recording of multichannel EEG

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

Diagnostic Test

The Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16) is a measure of depression symptom severity that has been validated for clinical and research use53. It is a standard self-report measurement completed by patients prior to each ECT session

Ictal Electroencephalographic (EEG) Measurements

Diagnostic Test

A high-density 65-electrode EEG scalp electrode net (EGI/Philips) with Elefix conductive gel injected within Ag/AgCl electrode sensors is utilized to monitor brain activity during the ictal period

Post-Ictal Electroencephalographic (EEG) Suppression Measurements

Diagnostic Test

A board-certified epileptologist will review all seizures to assess seizure parameters, including duration of seizure and interval of PGES. Preprocessing of the PGES periods will be accomplished with band-pass filtering from 2 to 30 Hz with 1st order Butterworth filters.

Primary outcomes

  1. Interval change in Quick Inventory of Depressive Symptomatology-16 Item Self Report (QIDS-SR16) between ECT sessions.

    Time frame: Up to 8 weeks during patients ECT treatment course

    16 item Self-report questionnaire that best describes the participant's depressive symptoms over the last seven days. Scale: 0=never or do not, 3=nearly all the time, or the highest level of time listed on the question.

  2. Duration of Central Positive Complexes during ECT treatments.

    Time frame: Up to 8 weeks during patients ECT treatment course

    Total time (in seconds) during the ictal period for which CPCs are present in the EEG immediately following seizure induction until termination of the seizure.

    Range of values: 0 - 300 seconds

  3. Duration of PGES during ECT treatments.

    Time frame: Up to 8 weeks during patients ECT treatment course

    Total time (in seconds) during the postictal period for which PGES is present in the EEG immediately following seizure termination for up to 5 minutes.

    Range of values: 0 - 300 seconds

  4. Density of EEG sleep spindles during non-rapid eye movement (NREM) stages N2 on evenings following ECT treatments.

    Time frame: Up to 8 weeks during patients ECT treatment course

    The total number of EEG sleep spindles per minute present during N2 sleep. Range of values: 0 - 60 spindles/min

  5. Slow wave activity (SWA) during N3 sleep on evenings following ECT treatments

    Time frame: Up to 8 weeks during patients ECT treatment course

    Total power of EEG slow waves per minute present during the first identified cycle of N3 sleep Range of values: 0 - 50 dB/min

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Correlating Electroconvulsive Therapy Response to Electroencephalographic Ictal Complexes and Postictal Markers

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Jun 30, 2020
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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