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NCT02935647 Clinical Trial

Burst Suppression Anesthesia for Treatment of Severe Depression

Major Depressive Disorder Clinical Trial

Official title:
Burst Suppression Anesthesia for Treatment of Severe Depression

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02935647
Other study ID # 00090838
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 1, 2016
Est. completion date September 2018

Study information
Verified date May 2021
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to determine if the antidepressant effects of deep anesthesia via propofol are related to EEG burst suppression.

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.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date September 2018
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Diprivan

Locations
Country Name City State
United States University Neuropsychiatric Institute Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hamilton Rating Scale for Depression 3 weeks
Secondary Quick Inventory of Depressive Symptoms 3 weeks
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