EEG Characteristics in ECT

Early Phase 1

Completed

• Conditions: Electroconvulsive Therapy; Direct Current Electroencephalogram; Ketamine; Spreadind Depression
• Interventions: Drug: Methohexital; Drug: Ketamine

• Registration Number: NCT04022226
• Lead Sponsor: University of New Mexico

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-12
• Study First Posted: 2019-07-17
• Study Start: 2019-10-01
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Results First Submitted: 2024-02-08
• Status Verified: 2024-08
• Results First Submitted QC: 2024-08-05
• Last Update Submitted: 2024-08-05
• Results First Posted: 2024-10-26
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methohexital	Methohexital	Standard of care anesthesia that does not affect slow wave characteristics
Ketamine	Ketamine	Standard of care anesthesia that suppresses slow wave characteristics

Primary Outcome Measures

Name	Time	Method
Number of Participants Assessed for Clinical Efficacy of ECT	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.

Trial Locations

Locations (1)

University of New Mexico Mental Health Center; 🇺🇸 Albuquerque, New Mexico, United States