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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on days of propofol infusions

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of Propofol Infusion - Propofol SWA

Feasibility of Propofol Infusion - Sleep SWA

Safety of Propofol Infusion

Secondary outcome measures

Affects on cognition (Fluid Cognition)

Affects on cognition (MoCA)

Affects on suicidality

+1 more

Other outcome measures

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,788 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,785 Previous Clinical Trials

2,689,270 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what circumstances is Slow-Wave Activity a typical treatment recommendation?

"Slow-Wave Activity is largely used as a sedative during medical procedures, but can also be utilized in monitored anesthesia care therapy, sedative therapy, and other anesthesia applications."

Answered by AI

How many individuals are currently participating in this medical research?

"Affirmative. Data hosted on clinicaltrials.gov demonstrates that this medical research, which was initially posted on January 14th 2021, is recruiting patients right now. A total of 85 volunteers must be recruited at one location."

Answered by AI

Could you elaborate on prior experiments regarding Slow-Wave Activity?

"Currently, there are 72 studies examining Slow-Wave Activity with 12 of those experiments at a Phase 3 level. The majority of research sites for this topic are located in Jinan, Shandong however; globally 251 clinical trial centres have been established to further investigate the potential therapeutic applications."

Answered by AI

Are there vacancies remaining in this clinical trial?

"Affirmative. Clinicaltrials.gov indicates that this investigation is currently seeking patients, initially posted on January 14th 2021 and last revised on September 14th 2022. Eighty-five individuals must be enrolled from a single site."

Answered by AI