NCT06867549 · Washington University School of Medicine
Slow Wave Induction by Propofol to Eliminate Depression (SWIPED) Stage II
(SWIPED II)
What this study is about
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 randomly assigned controlled trial.
View original scientific description
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.
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.
Primary outcome measures
Change in SWS duration
Time frame: Pre-infusion and on the nights of propofol infusions
This is the total duration of N3 averaged across infusion nights relative to baseline average. The average change in total duration of N3 infusion nights relative to baseline.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- St Louis, Missouri
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 27, 2026 · Source of record for eligibility and locations