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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04022226
Other study ID # 19-228
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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