EEG Characteristics in ECT

Ketamine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04022226
• Other study ID #: 19-228
• Status: Completed
• Phase: Early Phase 1
• Start date: October 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: June 2022
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Direct Current Electroencephalogram
• Electroconvulsive Therapy
• Ketamine
• Spreadind Depression

Intervention

Drug:
• Ketamine
Induction agent that suppresses infra-slow waves
• Methohexital
Induction agent that does not suppress infra-slow waves

Locations

Country	Name	City	State
United States	University of New Mexico Mental Health Center	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Outcome measures will be assessed the first, second, middle, and final ECT treatment over the course of 1 month on average for each patient. Data will be reported at 1 year.
Secondary	Cognitive performance	Montreal Cognitive Assessment. Measures global cognitive function. 0-30 with higher score indicates better cognitive function; Dot Counting Test measures effort. Time to completion and errors recorded. Higher times/error rates indicate decreased effort; Test of Premorbid Function estimates premorbid intellectual function. Negative change indicates greater cognitive & memory function impairment; Autobiographical Memory Test. Free recall of retrospective autobiographical memories. 0-20 with higher score indicating improved memory function; Hopkins Verbal Learning Test-Revised. Free recall, and recognition memory. Retention % calculated. Higher percentage indicates improved cognitive function; Delis Kaplan Executive Function System Color-Word Interference & Verbal Fluency Test. Processing speed, sequencing and cognitive flexibility; This neuropsychological battery will be used to compute composite z-scores that represent global cognitive function at each time point	Outcome measures assessed at first, second, middle, and final ECT treatment over the course of 1 month on average for each patient. Data will be reported at 1 year.
Secondary	Direct current electroencephalogram slow wave phenomenon (exploratory outcome)	Analysis will assess magnitude of slow-wave phenomena (area under the curve in cm^2)	dcEEG data will be collected the first, second, middle, and final ECT treatment over the course of 1 month on average for each patient. Data will be reported at 1 year.
Secondary	ECT parameters and their correlation to production of slow-wave phenomenon	Analysis will correlate electrode placement and pulse width with production of slow-waves on dcEEG.	This will be assessed throughout the year.