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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03684447
Other study ID # 00116093
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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