Skip to main content
OpenTrials
Completed

NCT Number: NCT04022226

EEG Characteristics in ECT

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Electroconvulsive Therapy Direct Current Electroencephalogram Ketamine Spreadind Depression

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of New Mexico Mental Health Center

Albuquerque, New Mexico, 87106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

ketamine

Drug

Induction agent that suppresses infra-slow waves

Methohexital

Drug

Induction agent that does not suppress infra-slow waves

Primary outcomes

  1. Number of Participants Assessed for Clinical Efficacy of ECT

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 17, 2019
Registry last updated
Oct 26, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.