Neural and Antidepressant Effects of Propofol (Phase 2)
NCT ID: NCT03923361
Last Updated: 2019-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2/PHASE3
INTERVENTIONAL
2019-04-16
2024-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Propofol
Diprivan
Similar to the high-intensity propofol treatments in Phase 1, the anesthesiologist will administer an induction dose of propofol followed by a continuous infusion, insert an airway, and begin mechanical ventilation. Propofol dosing will be adjusted with the goal of achieving a burst-suppression state with a SR of 40-60 for 12-15 minutes.
Interventions
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Diprivan
Similar to the high-intensity propofol treatments in Phase 1, the anesthesiologist will administer an induction dose of propofol followed by a continuous infusion, insert an airway, and begin mechanical ventilation. Propofol dosing will be adjusted with the goal of achieving a burst-suppression state with a SR of 40-60 for 12-15 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of major depressive disorder or bipolar disorder
* Current moderate-to-severe depressive episode
* Episode duration more than 2 months and less than 5 years
* Failure of at least 2 adequate antidepressant medication trials within the past 2 years
* Body mass index \< 40
* 16-item Quick Inventory of Depressive Symptomatology, self-rated \> 10
Exclusion Criteria
* Daily use of benzodiazepine, opioid, ACE inhibitor, or ARB medication
* Symptomatic coronary artery disease or heart failure
* Poorly controlled hypertension or diabetes
* Abnormal kidney or liver function
* Pregnant or breast feeding
* Traumatic brain injury or significant neurologic signs (past year)
* Substance use disorder (past year)
* Obsessive compulsive disorder (current)
* Post-traumatic stress disorder (current)
* Schizophrenia-spectrum disorder (lifetime)
* Neurocognitive disorder (current)
* Personality disorder as a current focus of treatment
* ECT within the past 3 months
* Inappropriate for ECT, or poor response to ECT within the past 5 years
* Incompetent to provide consent
18 Years
55 Years
ALL
No
Sponsors
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University of Utah
OTHER
Responsible Party
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Brian Mickey
Principal Investigator
Locations
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Univeristy Neuropsychiatric Institute
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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00116093B
Identifier Type: -
Identifier Source: org_study_id