Propofol-Induced Sleep for Depression

Recruiting in Palo Alto (17 mi)

Overseen byBen Palanca, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?

Our hypothesis is that targeted propofol infusion in treatment-resistant depressed patients will induce slow wave activity during sedation and augment subsequent sleep slow wave activity. We will recruit 15 participants for this open label single arm Phase I trial. All participants will undergo two propofol infusions 2-6 days apart, with each infusion maximizing expression of EEG slow waves. To minimize bias, there will be no specific gender or ethnic background consideration for enrollment. This will be a single site investigation at Washington University Medical Center.

Eligibility Criteria

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.

Inclusion Criteria

I speak English.

I am 60 years old or older.

I have major depression that didn't improve with at least two different antidepressants.

Exclusion Criteria

Your body mass index (BMI) is higher than 35.

I have symptoms of heart disease.

You have a score of 4 or higher on a test called Columbia-Suicide Severity Rating Scale (C-SSRS).

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Treatment Details

Interventions

Propofol (General Anesthetic)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Propofol infusionExperimental Treatment3 Interventions

Serial propofol infusions to maximally and safely induce unconsciousness and EEG slow waves while minimizing burst suppression.