search
Back to results

Neural and Antidepressant Effects of Propofol

Primary Purpose

Treatment Resistant Depression

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Propofol
Propofol
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Depression

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • University Neuropsychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Propofol High Dose

Propofol Low Dose

Arm Description

high propofol injectable, individually dosed, three times per week

low propofol injectable, individually dosed, three times per week

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 17, 2018
Last Updated
October 26, 2022
Sponsor
University of Utah
search

1. Study Identification

Unique Protocol Identification Number
NCT03684447
Brief Title
Neural and Antidepressant Effects of Propofol
Official Title
Neural and Antidepressant Effects of Propofol
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 21, 2019 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Model Description
Participants randomized to the high dose will exit the study after treatment. Participants randomized to the low dose who have not experienced response are able to crossover to the high dose.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Propofol High Dose
Arm Type
Experimental
Arm Description
high propofol injectable, individually dosed, three times per week
Arm Title
Propofol Low Dose
Arm Type
Experimental
Arm Description
low propofol injectable, individually dosed, three times per week
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
Series of 6 treatments with propofol.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
Series of 6 treatments with propofol. May be able to cross over and receive 6 additional treatments with the high dose of propofol.
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale
Description
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
Time Frame
approximately 17 days after randomization
Secondary Outcome Measure Information:
Title
Hamilton Depression Rating Scale
Description
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
Time Frame
approximately 36 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian J Mickey, MD, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Neuropsychiatric Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Neural and Antidepressant Effects of Propofol

We'll reach out to this number within 24 hrs