Neural and Antidepressant Effects of Propofol (Phase 2)
Primary Purpose
Treatment Resistant Depression
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Diprivan
Sponsored by
About this trial
This is an interventional treatment trial for Treatment Resistant Depression
Eligibility Criteria
Inclusion Criteria:
- Age 18-55
- 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:
- Contraindication to propofol or midazolam
- 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
Sites / Locations
- Univeristy Neuropsychiatric Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Propofol
Arm Description
Outcomes
Primary Outcome Measures
Hamilton Rating Scale for Depression
24-item Hamilton Depression Rating Scale, total score Higher values represent more severe depressive symptoms Maximum score, 76; minimum score, 0 Remission defined as total score < 10 Response defined as decrease of total score from baseline > 50%
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03923361
Brief Title
Neural and Antidepressant Effects of Propofol (Phase 2)
Official Title
Neural and Antidepressant Effects of Propofol (Phase 2)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Change in study design based on phase 1 data collection; patient burden was not feasible
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Moderate-intensity propofol treatments will be administered to participants who are non-responders at the end of Phase 1.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propofol
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Diprivan
Other Intervention Name(s)
Propofol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression
Description
24-item Hamilton Depression Rating Scale, total score Higher values represent more severe depressive symptoms Maximum score, 76; minimum score, 0 Remission defined as total score < 10 Response defined as decrease of total score from baseline > 50%
Time Frame
3 weeks after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-55
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:
Contraindication to propofol or midazolam
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
Facility Information:
Facility Name
Univeristy Neuropsychiatric Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Neural and Antidepressant Effects of Propofol (Phase 2)
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