Clinical Trial

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

Study acronym: SWIPED II
Recruiting Phase 2
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-03-04; most recent amendment 2025-10-22.
Status change: Not Yet Recruiting → Recruiting 2025-03-07
Trial Details
NCT Number NCT06867549
Lead Sponsor Washington University School of Medicine
Collaborators: National Institute of Mental Health (NIMH)
Conditions Depression
Enrollment 70 participants
Start Date 2025-03-04
Primary Completion 2028-02-01 (estimated)
Study Completion 2028-04-01 (estimated)
Updated on ClinicalTrials.gov 2025-10-24