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Completed

NCT Number: NCT02935647

Burst Suppression Anesthesia for Treatment of Severe Depression

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

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Neuropsychiatric Institute

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Diprivan

Drug

Other names: Propofol

Primary outcomes

  1. Hamilton Rating Scale for Depression

    Time frame: 3 weeks

Secondary outcomes

  1. Quick Inventory of Depressive Symptoms

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 17, 2016
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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