Burst Suppression Anesthesia for Treatment of Severe Depression

University of Utah1 site in 1 country11 target enrollmentOctober 1, 2016

ConditionsMajor Depressive Disorder

InterventionsDiprivan

DrugsDiprivan

Overview

Phase: Phase 1
Intervention: Diprivan
Conditions: Major Depressive Disorder
Sponsor: University of Utah
Enrollment: 11
Locations: 1
Primary Endpoint: Hamilton Rating Scale for Depression
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 1, 2016

End Date

September 2018

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Utah

Responsible Party

Principal Investigator

Brian Mickey

Principal Investigator

University of Utah

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

Arms & Interventions

Propofol

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: Diprivan