Burst Suppression Anesthesia for Treatment of Severe Depression

Utah System of Higher Education (USHE)

Status and phase: Completed; Phase 1

Conditions: Major Depressive Disorder

Treatments: Drug: Diprivan

Study type: Interventional

Funder types: Other

Identifiers

NCT02935647

00090838

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Propofol

Experimental group

Description:

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.

Treatment:

Drug: Diprivan