RecruitingPhase 2NCT06867549

Slow Wave Induction by Propofol to Eliminate Depression (SWIPED) Stage II

Sponsor

Washington University School of Medicine

Enrollment

70 participants

Start Date

Mar 4, 2025

Study Type

INTERVENTIONAL

Conditions

Depression

Summary

The investigators hypothesize that brief behavioral therapy and targeted propofol infusion in depressed geriatric patients will augment subsequent slow wave sleep and improve clinical and cognitive outcomes. The team will recruit 70 participants for a double-blinded placebo controlled randomized controlled trial. Two propofol infusions, 2-6 days apart, will be administered, targeting either a low propofol dose arm (minimal EEG slow waves, brain effect-site concentration 1-2 mcg/ml) or moderate dose propofol arm (maximal induction of EEG slow waves, brain effect site concentration of \>2.5 mcg/ml). The pharmacologic intervention will be paired with 3-4 sessions of Brief Behavioral Therapy for Insomnia for all participants. 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

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether low-dose propofol infusions (a sedation drug) given over several sessions can reduce depression symptoms in older adults — similar in concept to how ketamine infusions have been used for treatment-resistant depression. **You may be eligible if...** - You are 60 years of age or older - You are English-speaking - You have been diagnosed with major depressive disorder or bipolar depression - Your depression has not responded adequately to at least two different antidepressant treatments **You may NOT be eligible if...** - You have a history of substance use disorder (especially alcohol or sedatives) - You have serious heart, breathing, or liver problems - You have active suicidal intent requiring immediate intervention - You are currently taking certain medications that interact with propofol (such as strong opioids) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPropofol

Targeted propofol infusion in TRD patients will induce sedation. Dosage of propofol is determined based upon EEG markers and treatment arm.

DIAGNOSTIC_TESTElectroencephalography (EEG)

EEG will be recorded during propofol infusion and during overnight sleep. Sleep EEG data will be acquired for a minimum of one night prior to the first sedation session, providing a baseline measure. Additional overnight sleep recordings will be performed on day of sedation and subsequent nights.

BEHAVIORALBrief Behavioral Therapy for Insomnia

Trained staff will provide evaluation and up to 3 follow up appointments of BBTI for all participants. These will be done remotely to assess behavioral approaches to improve overall sleep habits.