Neural and Antidepressant Effects of Propofol

Treatment Resistant Depression Clinical Trial

Official title:

Neural and Antidepressant Effects of Propofol

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03684447
• Other study ID #: 00116093
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: April 21, 2019
• Est. completion date: July 2024

Study information

• Verified date: May 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: July 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Intervention

Drug:
• Propofol
Series of 6 treatments with propofol.
• Propofol
Series of 6 treatments with propofol. May be able to cross over and receive 6 additional treatments with the high dose of propofol.

Locations

Country	Name	City	State
United States	University Neuropsychiatric Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale	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	approximately 17 days after randomization
Secondary	Hamilton Depression Rating Scale	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	approximately 36 days after randomization