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General Anesthetic
Propofol-Induced Sleep for Depression
Phase 1 & 2
Recruiting
Led By Ben Palanca, MD PhD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age of at least 60 years
History of Treatment-Resistant Major Depressive Disorder (defined as non-responsiveness to at least two adequate trials of oral antidepressant medications)
Must not have
Symptomatic coronary artery disease
Symptomatic congestive heart failure/cardiomyopathy (New York Heart Association > Class III or left ventricular ejection fraction < 40%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on days of propofol infusions
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial is testing if a sleep aid can help people with depression who haven't responded to other treatments.
Who is the study for?
This trial is for English-speaking individuals aged 60 or older with a history of treatment-resistant major depressive disorder, which means depression that hasn't improved after trying at least two different oral antidepressants. Participants must be cognitively sharp (MOCA score ≥ 23) and not have severe heart issues, propofol allergies, high suicide risk, extreme obesity (BMI ≤ 35), or current treatments like ECT/TMS or active vagal nerve implants.
What is being tested?
The SWIPED trial is testing whether propofol can help treat depression by inducing slow wave activity in the brain during sedation. This Phase I study involves giving participants two doses of propofol a few days apart to see if it improves their EEG slow waves and subsequent sleep quality. It's an open-label trial without placebo control conducted at Washington University Medical Center.
What are the potential side effects?
Propofol may cause side effects such as pain at the injection site, low blood pressure, drowsiness post-treatment, and in rare cases allergic reactions. Since this study focuses on brain activity changes with EEG monitoring during sedation, there might also be risks associated with prolonged immobility.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 60 years old or older.
Select...
I have major depression that didn't improve with at least two different antidepressants.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have symptoms of heart disease.
Select...
I have severe heart failure or my heart pumps poorly.
Select...
I am currently undergoing electroconvulsive therapy or transcranial magnetic stimulation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over three-week period of pre- and post- infusion sleep recordings
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over three-week period of pre- and post- infusion sleep recordings
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of Propofol Infusion - Propofol SWA
Feasibility of Propofol Infusion - Sleep SWA
Safety of Propofol Infusion
Secondary study objectives
Affects on cognition (Fluid Cognition)
Affects on cognition (MoCA)
Affects on suicidality
+1 moreOther study objectives
Feasibility of acquiring propofol-associated changes in affect
Feasibility of acquiring propofol-associated changes in anhedonia
Feasibility of acquiring propofol-associated changes in circadian rhythms
+1 moreAwards & Highlights
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.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Propofol infusion - moderate doseExperimental Treatment3 Interventions
Serial propofol infusions to maximally and safely induce unconsciousness and EEG slow waves while minimizing burst suppression.
Group II: Propofol infusion - low doseActive Control3 Interventions
Serial propofol infusions to safely induce unconsciousness while minimizing EEG slow waves and burst suppression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Electroencephalography (EEG)
2019
N/A
~360
Propofol
FDA approved
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,991 Previous Clinical Trials
2,295,775 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,740,048 Total Patients Enrolled
Ben Palanca, MD PhDPrincipal Investigator - Washington University School of Medicine
Barnes-Jewish Hospital
Washington University School Of Medicine (Medical School)
Washington U/B-Jh/Slch Conc (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index (BMI) is higher than 35.I have symptoms of heart disease.I speak English.You have a score of 4 or higher on a test called Columbia-Suicide Severity Rating Scale (C-SSRS).I am 60 years old or older.You currently have an implanted vagal nerve device that is in use.Your heart beats too slowly when you are at rest.You scored less than 23 on a test called the Montreal Cognitive Assessment (MOCA).I have severe heart failure or my heart pumps poorly.I am currently undergoing electroconvulsive therapy or transcranial magnetic stimulation.I have major depression that didn't improve with at least two different antidepressants.
Research Study Groups:
This trial has the following groups:- Group 1: Propofol infusion - moderate dose
- Group 2: Propofol infusion - 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.
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