Neural and Antidepressant Effects of Propofol

Phase 2

Active, not recruiting

• Conditions: Treatment Resistant Depression
• Interventions: Drug: Propofol

• Registration Number: NCT03684447
• Lead Sponsor: University of Utah

Brief Summary

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

Detailed 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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-09-17
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-25
• Study Start: 2019-04-21
• Primary Completion: 2022-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Propofol High Dose	Propofol	high propofol injectable, individually dosed, three times per week
Propofol Low Dose	Propofol	low propofol injectable, individually dosed, three times per week

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale	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 Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale	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

Trial Locations

Locations (1)

University Neuropsychiatric Institute; 🇺🇸 Salt Lake City, Utah, United States