EEG Characteristics in ECT

• ClinicalTrials.gov Identifier: NCT04022226
• Recruitment Status: Unknown
• First Posted: July 17, 2019
• Last Update Posted: July 19, 2019
• Sponsor: University of New Mexico
• Collaborator: University of New Mexico Clinical & Translational Science Center
• Information provided by (Responsible Party): Jeremy Miller, University of New Mexico

Tracking Information

• First Submitted Date: July 10, 2019
• First Posted Date: July 17, 2019
• Last Update Posted Date: July 19, 2019
• Estimated Study Start Date: October 1, 2019
• Estimated Primary Completion Date: October 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 12, 2019)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 16, 2019)

• 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
• 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)
• 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.

Original Secondary Outcome Measures (submitted: July 12, 2019)

• 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
• 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)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: EEG Characteristics in ECT
• Official Title: A Randomized Pilot Study Examining DCEEG Characteristics in Ketamine Versus Methohexital Induction in Depressed Patients Receiving Electroconvulsive Therapy
• 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 Type: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Diagnostic

Condition

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

Intervention

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

Study Arms

• Active Comparator: Methohexital
  Standard of care anesthesia that does not affect slow wave characteristics
  Intervention: Drug: Methohexital
• Experimental: Ketamine
  Standard of care anesthesia that suppresses slow wave characteristics
  Intervention: Drug: Ketamine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 12, 2019): 26
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 1, 2020
• Estimated Primary Completion Date: October 1, 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04022226
• Other Study ID Numbers: 19-228
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Supporting Materials: 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/

• Responsible Party: Jeremy Miller, University of New Mexico
• Study Sponsor: University of New Mexico
• Collaborators: University of New Mexico Clinical & Translational Science Center
• Investigators: Not Provided
• PRS Account: University of New Mexico
• Verification Date: July 2019