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EEG Characteristics in ECT

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ClinicalTrials.gov Identifier: NCT04022226
Recruitment Status : Not yet recruiting
First Posted : July 17, 2019
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
University of New Mexico Clinical & Translational Science Center
Information provided by (Responsible Party):
Jeremy Miller, 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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 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
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


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




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04022226


Locations
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United States, New Mexico
University of New Mexico Mental Health Center Not yet recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Jeremy Miller, MD    505-272-4490    jermiller@salud.unm.edu   
Principal Investigator: Jeremy Miller, MD         
Sponsors and Collaborators
University of New Mexico
University of New Mexico Clinical & Translational Science Center

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Responsible Party: Jeremy Miller, Attending Psychiatrist, University of New Mexico
ClinicalTrials.gov Identifier: NCT04022226     History of Changes
Other Study ID Numbers: 19-228
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
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/

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

Additional relevant MeSH terms:
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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