Neural and Antidepressant Effects of Propofol

Utah System of Higher Education (USHE)

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Treatment Resistant Depression

Treatments: Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT03684447

00116093

Details and patient eligibility

About

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

Full description

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

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

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups

Propofol High Dose

Experimental group

Description:

high propofol injectable, individually dosed, three times per week

Treatment:

Drug: Propofol

Drug: Propofol

Propofol Low Dose

Experimental group

Description:

low propofol injectable, individually dosed, three times per week

Treatment:

Drug: Propofol

Drug: Propofol