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The investigators will be examining slow-wave characteristics in depressed patients receiving electroconvulsive therapy (ECT) using direct current electroencephalogram (dcEEG) by anesthesia induction agent.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methohexital | Active Comparator | Standard of care anesthesia that does not affect slow wave characteristics |
|
| Ketamine | Experimental | Standard of care anesthesia that suppresses slow wave characteristics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Induction agent that suppresses infra-slow waves |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Assessed for 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. Inadequate sample size due to COVID. Study was closed. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Mental Health Center | Albuquerque | New Mexico | 87106 | United States |
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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.
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.
We had initially envisioned this as a randomized trial, but due to COVID, we restricted it to a single-arm study.
The funding cycle was cut short secondary to COVID and it was decided to analyze DCEEG Characteristics with only one arm, the Methohexital arm (standard of care). The Ketamine arm was cancelled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Methohexital | Standard of care anesthesia that does not affect slow wave characteristics Methohexital: Induction agent that does not suppress infra-slow waves |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methohexital | Standard of care anesthesia that does not affect slow wave characteristics Methohexital: Induction agent that does not suppress infra-slow waves |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Assessed for 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. Inadequate sample size due to COVID. Study was closed. | Posted | Count of Participants | Participants | 1 year |
|
|
No adverse outcome were reported within the 1 year timeframe.
same definition
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methohexital | Standard of care anesthesia that does not affect slow wave characteristics Methohexital: Induction agent that does not suppress infra-slow waves |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeremy Miller | The University of New Mexico | 5052724490 | jermiller@salud.unm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 5, 2019 | Aug 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D008723 | Methohexital |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Methohexital |
| Drug |
Induction agent that does not suppress infra-slow waves |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001463 | Barbiturates |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |