Back to resultsEndogenous Opioid Modulation by Ketamine
Primary Purpose
Major Depressive Disorder
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ketamine Hydrochloride
Normal saline
Sponsored by
About this trial
This is an interventional basic science trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- Age 18-65
- 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:
- Current episode duration >5 years
- 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
Sites / Locations
- Huntsman Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ketamine
Placebo
Arm Description
Ketamine will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total).
Normal saline will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total).
Outcomes
Primary Outcome Measures
Hamilton Depression Rating Scale at 24 hours, change from baseline
total score on the 17-item Hamilton Depression Rating Scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03051945
Brief Title
Endogenous Opioid Modulation by Ketamine
Official Title
Endogenous Opioid Modulation by Ketamine
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to perform brain imaging
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Demonstrate the acute effects of ketamine on endogenous µ-opioid neurotransmission in humans.
Detailed Description
This study will test the hypothesis that the rapidly-acting antidepressant ketamine improves core depressive symptoms by acutely activating the brain's endogenous µ-opioid system.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketamine
Arm Type
Experimental
Arm Description
Ketamine will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total).
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Normal saline
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale at 24 hours, change from baseline
Description
total score on the 17-item Hamilton Depression Rating Scale
Time Frame
24 hr
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-65
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:
Current episode duration >5 years
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
Facility Information:
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Endogenous Opioid Modulation by Ketamine
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