Back to resultsBurst Suppression Anesthesia for Treatment of Severe Depression
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Diprivan
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
• Diagnosis of Major Depressive Disorder (MDD) or bipolar Disorder (I or II, most recent episode must be depression
- Failed at least 2 anti-depressant treatments and no ECT in past 6 months
- Age between 18-55 years
- BMI < 35
- Hamilton Rating Scale for Depression (HSRD) score > 18
- Quick Inventory of Depression Scale (QIDS) score > 10.
Exclusion Criteria:
• Diagnosis of primary psychotic disorder, dysthymia, or personality disorder
- Significant pre-morbid cognitive impairment
- Hypertension and current use of ACE inhibitor or AR blocker medications
- Symptomatic coronary artery disease or congestive heart failure
- History of transient ischemic or neurologic signs during the past year
- History of or susceptibility to malignant hyperthermia
- Contraindication to isoflurane or propofol anesthesia (as determined by anesthesiologist)
- Diabetes requiring insulin
- Poor kidney function
- Chronic use of benzodiazepines or opioids
- Individuals incompetent to provide consent (e.g. catatonic, psychotic).
Sites / Locations
- University Neuropsychiatric Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Propofol
Arm Description
Participants will receive intravenous propofol titrated rapidly at 100-200 mcg/kg/min to reach 80% burst-suppression and then maintained there for 15 minutes, after which propofol administration will be discontinued and the participant will be allowed to awaken.
Outcomes
Primary Outcome Measures
Hamilton Rating Scale for Depression
Secondary Outcome Measures
Quick Inventory of Depressive Symptoms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02935647
Brief Title
Burst Suppression Anesthesia for Treatment of Severe Depression
Official Title
Burst Suppression Anesthesia for Treatment of Severe Depression
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to determine if the antidepressant effects of deep anesthesia via propofol are related to EEG burst suppression.
Detailed Description
Ten individuals with treatment resistant major depressive disorder will undergo 10 treatments of deep anesthesia via propofol over a 3-week period. Depression will be evaluated before and after treatment.
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
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propofol
Arm Type
Experimental
Arm Description
Participants will receive intravenous propofol titrated rapidly at 100-200 mcg/kg/min to reach 80% burst-suppression and then maintained there for 15 minutes, after which propofol administration will be discontinued and the participant will be allowed to awaken.
Intervention Type
Drug
Intervention Name(s)
Diprivan
Other Intervention Name(s)
Propofol
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptoms
Time Frame
3 weeks
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:
• Diagnosis of Major Depressive Disorder (MDD) or bipolar Disorder (I or II, most recent episode must be depression
Failed at least 2 anti-depressant treatments and no ECT in past 6 months
Age between 18-55 years
BMI < 35
Hamilton Rating Scale for Depression (HSRD) score > 18
Quick Inventory of Depression Scale (QIDS) score > 10.
Exclusion Criteria:
• Diagnosis of primary psychotic disorder, dysthymia, or personality disorder
Significant pre-morbid cognitive impairment
Hypertension and current use of ACE inhibitor or AR blocker medications
Symptomatic coronary artery disease or congestive heart failure
History of transient ischemic or neurologic signs during the past year
History of or susceptibility to malignant hyperthermia
Contraindication to isoflurane or propofol anesthesia (as determined by anesthesiologist)
Diabetes requiring insulin
Poor kidney function
Chronic use of benzodiazepines or opioids
Individuals incompetent to provide consent (e.g. catatonic, psychotic).
Facility Information:
Facility Name
University Neuropsychiatric Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30260415
Citation
Mickey BJ, White AT, Arp AM, Leonardi K, Torres MM, Larson AL, Odell DH, Whittingham SA, Beck MM, Jessop JE, Sakata DJ, Bushnell LA, Pierson MD, Solzbacher D, Kendrick EJ, Weeks HR 3rd, Light AR, Light KC, Tadler SC. Propofol for Treatment-Resistant Depression: A Pilot Study. Int J Neuropsychopharmacol. 2018 Dec 1;21(12):1079-1089. doi: 10.1093/ijnp/pyy085.
Results Reference
derived
Learn more about this trial
Burst Suppression Anesthesia for Treatment of Severe Depression
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