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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06867549
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Propofol — DRUG
    Targeted propofol infusion in TRD patients will induce sedation. Dosage of propofol is determined based upon EEG markers and treatment arm.
  • Electroencephalography (EEG) — DIAGNOSTIC_TEST
    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.
  • Brief Behavioral Therapy for Insomnia — BEHAVIORAL
    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.

Study Details

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 Dates

Start date
Mar 4, 2025
Status verified
Oct 2025
Primary completion
Feb 1, 2028
Completion
Apr 1, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Propofol infusion -moderate dose
    Serial propofol infusions to maximally and safely induce unconsciousness and EEG slow waves while minimizing burst suppression. Target brain effect-site concentrations \>2.5 mcg/ml. This will be paired with BBTI.
  • Active Comparator: Propofol infusion - low dose
    Serial propofol infusions to safely induce unconsciousness while minimizing EEG slow waves and burst suppression.Target brain effect-site concentration of 1-2 mcg/ml. This will be paired with BBTI.

Primary Outcome Measure

Change in SWS duration [ Time Frame: Pre-infusion and on the nights of propofol infusions ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of Medicine/Barnes-Jewish HospitalSt LouisMissouri63110
Sarah E Knarr
[email protected]
314-362-2415
Ben Palanca, MD PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Washington University School of Medicine/Barnes-Jewish Hospital· St Louis, MO

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