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OpenTrials
Completed

NCT Number: NCT03684447

Neural and Antidepressant Effects of Propofol

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Neuropsychiatric Institute

Salt Lake City, Utah, 84108, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Propofol

Drug

Series of 6 treatments with propofol.

Other names: Diprivan

Primary outcomes

  1. Hamilton Depression Rating Scale

    Time frame: approximately 17 days after randomization

    24-item Hamilton Depression Rating Scale, total score Higher values represent more severe depressive symptoms Maximum score, 76; minimum score, 0 Remission defined as total score < 10 Response defined as decrease of total score from baseline of 50% or greater

Secondary outcomes

  1. Hamilton Depression Rating Scale

    Time frame: approximately 36 days after randomization

    24-item Hamilton Depression Rating Scale, total score Higher values represent more severe depressive symptoms Maximum score, 76; minimum score, 0 Remission defined as total score < 10 Response defined as decrease of total score from baseline of 50% or greater

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 25, 2018
Registry last updated
Sep 9, 2026

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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