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

Inclusion Criteria5

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Age 60 or greater
English speaking (as an interpreter will not be readily available should a participant need to convey any safety concerns during the propofol infusion sessions or require guidance on conducting at-home sleep recordings)
Depression (non-responsive to at least one adequate trial of oral antidepressants for current episode).

Exclusion Criteria14

Presence of symptomatic coronary artery disease
Presence of marked congestive heart failure/cardiomyopathy(NYHA \> Class III, LVEF \<40%, greater than mild RV systolic dysfunction)
Prior reaction to propofol
Resting heart rate \< 50 bpm
Treatment with Electroconvulsive therapy/Transcranial Magnetic Stimulation/vagal nerve stimulation within 6 weeks
Body mass index \> 35
C-SSRS of 4 or greater (active suicidal ideation with some intent and with/without a specific plan)
MoCA score \< 23 (at least mild dementia)
Schizophrenia
Bipolar disorder
Non-prescribed use of amphetamines, opioids, cocaine, or phencyclidine; Urine THC \> 150 ng/ml
Intake of \> 14 beers/week (or equivalent)
Anesthetic exposure in the past 4 weeks
Concurrent use of benzodiazepines \> 2 mg/day lorazepam or equivalent, trazodone \> 50 mg/day, or gabapentin \> 600mg/day.

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.