Burst Suppression Anesthesia for Treatment of Severe Depression

Phase 1

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Diprivan

• Registration Number: NCT02935647
• Lead Sponsor: University of Utah

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-17
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-28
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Propofol	Diprivan	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.

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression	3 weeks

Secondary Outcome Measures

Name	Time	Method
Quick Inventory of Depressive Symptoms	3 weeks

Trial Locations

Locations (1)

University Neuropsychiatric Institute; 🇺🇸 Salt Lake City, Utah, United States