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WITHDRAWN
PHASE3
INTERVENTIONAL
2019-08-31
2019-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Ketamine
Ketamine will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total).
Ketamine Hydrochloride
Study drug will be infused while the participant sits or lies in a comfortable position. The dose of ketamine used does not cause unconsciousness but may cause perceptual disturbances.
Placebo
Normal saline will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total).
Normal saline
Placebo
Interventions
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Ketamine Hydrochloride
Study drug will be infused while the participant sits or lies in a comfortable position. The dose of ketamine used does not cause unconsciousness but may cause perceptual disturbances.
Normal saline
Placebo
Eligibility Criteria
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Inclusion Criteria
* DSM-5 major depressive disorder
* Current moderate-to-severe, treatment-resistant, depressive episode
* Patient Health Questionnaire (PHQ-9) total score ≥ 10
* PHQ-9 item score ≥ 2 on "Little interest or pleasure" item
* PHQ-9 item score ≥ 2 on "Feeling down, depressed, or hopeless" item
* Medical documentation of depression for at least 2 months
* Inadequate response to at least one adequate antidepressant medication trial in the current episode
Exclusion Criteria
* Moderate-to-severe DSM-5 substance use disorder (past year)
* Cognitive disorder (past year)
* Post-traumatic stress disorder (past year)
* Obsessive compulsive disorder (past year)
* Personality disorder (past year)
* Positive urine drug screen
* Psychotic symptoms
* Mania
* Significant neurologic disorder or injury
* Breastfeeding or pregnancy
* Imminent suicide risk
* Current use of CYP3A4 inhibitors (e.g., ketoconazole or erythromycin)
* Other unstable psychiatric or medical condition requiring a higher level of care
* Contraindication to ketamine, MRI, or PET
18 Years
65 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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Huntsman Cancer Institute
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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00087544
Identifier Type: -
Identifier Source: org_study_id
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