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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

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 below
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I am 60 years old or older.
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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:
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I have symptoms of heart disease.
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I have severe heart failure or my heart pumps poorly.
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I am currently undergoing electroconvulsive therapy or transcranial magnetic stimulation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over three-week period of pre- and post- infusion sleep recordings
This trial's timeline: 3 weeks for screening, Varies for treatment, and over three-week period of pre- and post- infusion sleep recordings for reporting.

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 more
Other 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 more

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
1,970 Previous Clinical Trials
2,308,538 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,869 Previous Clinical Trials
2,777,451 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

Propofol (General Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04680910 — Phase 1 & 2
Major Depressive Disorder Research Study Groups: Propofol infusion - moderate dose, Propofol infusion - low dose
Major Depressive Disorder Clinical Trial 2023: Propofol Highlights & Side Effects. Trial Name: NCT04680910 — Phase 1 & 2
Propofol (General Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04680910 — Phase 1 & 2
~21 spots leftby Dec 2025
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