Overview

Neural and Antidepressant Effects of Propofol

Status:
Recruiting

Trial end date:
2024-07-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Utah

Treatments:

Antidepressive Agents
Midazolam
Propofol

Criteria

Inclusion Criteria:

Age 18-55 years 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 Failure of at least 2 adequate antidepressant medication trials within the past 2
years 16-item Quick Inventory of Depressive Symptomatology, self-rated (QIDS) > 10 24-item
Hamilton Depression Rating Scale (HDRS) > 18

Exclusion Criteria:

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 3months Inappropriate for ECT, or poor response to ECT within the past
5 years Incompetent to provide consent