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
• Status: Completed
• Phase: Phase 1
• 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
• 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).

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

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