Principal Investigator: Brian Mickey
Keywords: Burst supression , Major Depressive Disorder , Propofol , Treatment Resistant Depression , Deep Anesthesia Department: Psychiatry
IRB Number: 00116093
Specialty: Psychiatry, Anesthesiology
Sub Specialties:
Recruitment Status: Recruiting

Contact Information

Rebecca Jacobs
rebecca.jacobs@utah.edu
8018297382

Brief Summary

Study Objectives

This study will compare the antidepressant effects of propofol at two different doses while measuring potential treatment-related biomarkers.

Aim 1:  Compare the clinical antidepressant effects of high-dose versus low-dose propofol.

Participants with treatment-resistant depression will receive propofol at two different doses in a blinded randomized controlled pilot trial.  We hypothesize that depressive symptoms will improve to a greater degree and more quickly with high-dose propofol compared to low-dose propofol. 

Aim 2:  Characterize the dose-dependent effects of propofol on brain function and gene expression

To clarify the mechanisms of propofol's putative antidepressant effects, several potentially informative biomarkers will be quantified before, during, and after treatment.  We hypothesize that propofol treatment will cause dose-dependent changes in:
            (a) intraoperative brain electrical activity
            (b) brain GABA and glutamate levels
            (c) functional connectivity of brain networks
            (d) peripheral gene expression
            (e) behavioral patterns of activity and sleep

 

Inclusion Criteria

Included

Age 18-65 years, where the population between 55-65 do not have any history of hypertension or cardiovascular disease

Diagnosis of major depressive disorder or bipolar disorder

Current moderate-to-severe depressive episode

Episode duration more than 2 months and less than 5 years

16-item Quick Inventory of Depressive Symptomatology, self-rated > 10

Exclusion Criteria

Excluded

Contraindication to propofol, egg lecithin, soybean oil, or other study drugs

Lifetime history of a serious suicide attempt (Gvion and Levi-Belz, 2018)

Recent suicidal behavior (past 3 months)

Body mass index > 40 kg/m2

Daily use of benzodiazepine, opioid, ACE inhibitor, or ARB medication

Symptomatic coronary artery disease or heart failure

Poorly controlled hypertension or diabetes

Abnormal kidney or liver function

Pregnant or breast feeding

Traumatic brain injury or significant neurologic signs (past year)

Substance use disorder, moderate-to-severe (past 3 months)

Obsessive compulsive disorder (past month)

Post-traumatic stress disorder (past month)

Schizophrenia-spectrum disorder (lifetime)

Neurocognitive disorder (past year)

Personality disorder as a current focus of treatment

ECT within the past 1 month

Inappropriate for ECT, or poor response to ECT within the past 5 years 

Incompetent to provide consent