Actively Recruiting
Slow Wave Induction by Propofol to Eliminate Depression (SWIPED) Stage II
Led by Washington University School of Medicine · Updated on 2025-10-24
70
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial 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 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.
CONDITIONS
Official Title
Slow Wave Induction by Propofol to Eliminate Depression (SWIPED) Stage II
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the study duration
- Age 60 years or older
- English speaking
- Diagnosis of depression not responding to at least one adequate trial of oral antidepressants for the current episode
You will not qualify if you...
- Presence of symptomatic coronary artery disease
- Marked congestive heart failure or cardiomyopathy (NYHA Class III or higher, LVEF less than 40%, or greater than mild right ventricular systolic dysfunction)
- Prior allergic or adverse reaction to propofol
- Resting heart rate below 50 beats per minute
- Recent treatment with Electroconvulsive therapy, Transcranial Magnetic Stimulation, or vagal nerve stimulation within 6 weeks
- Body mass index over 35
- Active suicidal ideation with some intent (C-SSRS score 4 or greater)
- Mild or greater dementia (MoCA score below 23)
- Diagnosis of schizophrenia or bipolar disorder
- Use of non-prescribed amphetamines, opioids, cocaine, or phencyclidine; urine THC level greater than 150 ng/ml
- Consumption of more than 14 beers per week or equivalent
- Anesthetic exposure within the past 4 weeks
- Concurrent use of benzodiazepines over 2 mg/day lorazepam equivalent, trazodone over 50 mg/day, or gabapentin over 600 mg/day
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine/Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
S
Sarah E Knarr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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