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RECRUITING
NCT06867549
PHASE2

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

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2025-03-04

Completion Date

2028-04-01

Last Updated

2025-10-24

Healthy Volunteers

No

Conditions

Interventions

DRUG

Propofol

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

DIAGNOSTIC_TEST

Electroencephalography (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.

BEHAVIORAL

Brief 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.

Locations (1)

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, United States