EEG Characteristics in ECT

• ClinicalTrials.gov Identifier: NCT04022226
• Recruitment Status: Completed
• First Posted: July 17, 2019
• Last Update Posted: June 13, 2022
• Sponsor: University of New Mexico
• Information provided by (Responsible Party): Jeremy Miller, University of New Mexico

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Electroconvulsive Therapy; Direct Current Electroencephalogram; Ketamine; Spreadind Depression	Drug: Ketamine; Drug: Methohexital	Early Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: A Randomized Pilot Study Examining DCEEG Characteristics in Ketamine Versus Methohexital Induction in Depressed Patients Receiving Electroconvulsive Therapy
• Actual Study Start Date: October 1, 2019
• Actual Primary Completion Date: October 1, 2020
• Actual Study Completion Date: October 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Methohexital; Standard of care anesthesia that does not affect slow wave characteristics	Drug: Methohexital; Induction agent that does not suppress infra-slow waves
Experimental: Ketamine; Standard of care anesthesia that suppresses slow wave characteristics	Drug: Ketamine; Induction agent that suppresses infra-slow waves

Outcome Measures

Primary Outcome Measures :

1. Clinical Efficacy of ECT [ Time Frame: 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. ]
   Quick Inventory of Depressive Symptomatology (QIDS) and Self Reporting version (QIDS-SR) - Range 0 - 48 with higher number indicating worsening depression.

Secondary Outcome Measures :

1. Cognitive performance [ Time Frame: 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. ]
   • 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

2. Direct current electroencephalogram slow wave phenomenon (exploratory outcome) [ Time Frame: 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. ]
   Analysis will assess magnitude of slow-wave phenomena (area under the curve in cm^2)
3. ECT parameters and their correlation to production of slow-wave phenomenon [ Time Frame: This will be assessed throughout the year. ]
   Analysis will correlate electrode placement and pulse width with production of slow-waves on dcEEG.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, New Mexico

University of New Mexico Mental Health Center

Albuquerque, New Mexico, United States, 87106

Sponsors and Collaborators

University of New Mexico

More Information

• Responsible Party: Jeremy Miller, Attending Psychiatrist, University of New Mexico
• ClinicalTrials.gov Identifier: NCT04022226
• Other Study ID Numbers: 19-228
• First Posted: July 17, 2019
• Last Update Posted: June 13, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: An embargo of 2 years will be placed on the data after Master's Thesis is published and placed into the vault to allow for publications. Afterwards, it will be available as along as the vault is maintained.
• Access Criteria: Pilot project is being done as a part of a Master's Thesis which will be uploaded to the University of New Mexico digital repository and may contain supporting information as above.
• URL: https://digitalrepository.unm.edu/

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Depression; Behavioral Symptoms; Ketamine; Methohexital; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action