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Burst Suppression Anesthesia for Treatment of Severe Depression

Sponsor
University of Utah (Other)
Overall Status
Completed
CT.gov ID
NCT02935647
Collaborator
(none)
11
Enrollment
1
Location
1
Arm
23
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Burst Suppression Anesthesia for Treatment of Severe Depression
Actual Study Start Date :
Oct 1, 2016
Actual Primary Completion Date :
Sep 1, 2018
Actual Study Completion Date :
Sep 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Diprivan
Other Names:
  • Propofol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Hamilton Rating Scale for Depression [3 weeks]

    Secondary Outcome Measures

    1. Quick Inventory of Depressive Symptoms [3 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Neuropsychiatric Institute Salt Lake City Utah United States 84108

    Sponsors and Collaborators

    • University of Utah

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Brian Mickey, Principal Investigator, University of Utah
    ClinicalTrials.gov Identifier:
    NCT02935647
    Other Study ID Numbers:
    • 00090838
    First Posted:
    Oct 17, 2016
    Last Update Posted:
    Jun 2, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Depressive Disorder
    Depressive Disorder, Major
    Propofol

    Study Results

    No Results Posted as of Jun 2, 2021