Burst Suppression Anesthesia for Treatment of Severe Depression
1 other identifier
interventional
11
1 country
1
Brief Summary
This study is designed to determine if the antidepressant effects of deep anesthesia via propofol are related to EEG burst suppression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 major-depressive-disorder
Started Oct 2016
Typical duration for phase_1 major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 13, 2016
CompletedFirst Posted
Study publicly available on registry
October 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedJune 2, 2021
May 1, 2021
1.9 years
October 13, 2016
May 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Hamilton Rating Scale for Depression
3 weeks
Secondary Outcomes (1)
Quick Inventory of Depressive Symptoms
3 weeks
Study Arms (1)
Propofol
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Neuropsychiatric Institute
Salt Lake City, Utah, 84108, United States
Related Publications (1)
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.
PMID: 30260415DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 13, 2016
First Posted
October 17, 2016
Study Start
October 1, 2016
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
June 2, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share