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General Anesthetic
Propofol for Depression
Phase 2 & 3
Waitlist Available
Led By Brian J Mickey, MD, PhD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Failure of at least 2 adequate antidepressant medication trials within the past 2 years
Age 18-55 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 36 days after randomization
Awards & highlights
Study Summary
This trial will compare how well two different doses of propofol work as an antidepressant, as well as any potential side effects.
Who is the study for?
This trial is for adults aged 18-55 with major depressive disorder or bipolar disorder, who've had a moderate-to-severe episode lasting 2 months to less than 5 years and haven't improved after trying at least two antidepressants in the past two years. Exclusions include contraindications to propofol, certain medical conditions, substance abuse issues, recent suicidal behavior, and pregnancy.Check my eligibility
What is being tested?
The study tests the antidepressant effects of propofol at two different doses. It also looks for biomarkers that might indicate how well the treatment works. Participants will be compared based on these varying doses to see which is more effective.See study design
What are the potential side effects?
Propofol can cause side effects like drowsiness, dizziness, nausea or vomiting. In some cases it may lead to allergic reactions due to its components such as egg lecithin or soybean oil.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've tried at least 2 antidepressants in the last 2 years without success.
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I am between 18 and 55 years old.
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I have been diagnosed with major depressive disorder or bipolar disorder.
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I am currently experiencing a severe episode of depression.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 36 days after randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 36 days after randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Hamilton Depression Rating Scale
Trial Design
2Treatment groups
Experimental Treatment
Group I: Propofol Low DoseExperimental Treatment1 Intervention
low propofol injectable, individually dosed, three times per week
Group II: Propofol High DoseExperimental Treatment1 Intervention
high propofol injectable, individually dosed, three times per week
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Propofol
FDA approved
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,102 Previous Clinical Trials
1,779,213 Total Patients Enrolled
Brian J Mickey, MD, PhDPrincipal InvestigatorUniversity of Utah
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've tried at least 2 antidepressants in the last 2 years without success.I am 18-55 years old with depression or bipolar disorder, not responding to 2 meds, and have been depressed for 2-60 months.I have not had electroconvulsive therapy in the last 3 months.I am unable to understand or sign a consent form.My condition has lasted more than 2 months but less than 5 years.I use benzodiazepine, opioid, ACE inhibitor, or ARB medication daily.I have heart problems like angina or heart failure.My blood pressure or diabetes is not well-managed.I am between 18 and 55 years old.I have been diagnosed with major depressive disorder or bipolar disorder.I am currently experiencing a severe episode of depression.I am allergic to propofol, egg lecithin, soybean oil, or similar substances.ECT was not suitable for me or did not work well in the last 5 years.I have not had a traumatic brain injury or significant neurological issues in the past year.My kidney or liver is not functioning properly.
Research Study Groups:
This trial has the following groups:- Group 1: Propofol High Dose
- Group 2: Propofol Low Dose
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Would this particular drug testing program be interested in candidates who are elderly?
"As this trial's inclusion criteria stipulate, the youngest patients that can enroll must be 18 years old whereas the oldest patients cannot exceed 55 years of age."
Answered by AI
What is Propofol's standard purpose in a hospital setting?
"Propofol is most often employed during medical procedures to keep patients sedated. It can also be used, however, as a form of therapy for conditions like monitored anesthesia care therapy and sedative therapy."
Answered by AI
Are there any historical data sets that we can compare with this Propofol research?
"There are 80 different ongoing clinical trials studying the efficacy of Propofol. 12 of those are large-scale Phase 3 trials. Although the majority of Propofol research is conducted in Jinan, Shandong, there are over 250 other medical facilities running similar studies."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Oregon
How old are they?
18 - 65
What site did they apply to?
University Neuropsychiatric Institute
What portion of applicants met pre-screening criteria?
Met criteria
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