Propofol + Therapy for Depression (SWIPED II Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByBen Palanca, MD PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Washington University School of Medicine

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for older adults with depression. Participants must be able to undergo propofol infusions and brief behavioral therapy for insomnia. There are no gender or ethnic restrictions, but other specific inclusion and exclusion criteria have not been provided.

Inclusion Criteria

I am 60 years old or older.

My depression didn't improve after trying at least one antidepressant.

Exclusion Criteria

I have been diagnosed with schizophrenia.

I have symptoms of heart artery disease.

I have severe heart failure or heart muscle issues.

I haven't had ECT, TMS, or vagal nerve stimulation in the last 6 weeks.

I take more than 2 mg/day of lorazepam, over 50 mg/day of trazodone, or more than 600 mg/day of gabapentin.

Participant Groups

The SWIPED Stage II trial tests if low or moderate doses of propofol can improve sleep and mental health in depressed elderly patients when combined with sleep-focused therapy. It's a double-blind study where participants won't know which dose they receive.

2Treatment groups

Experimental Treatment

Active Control

Group I: Propofol infusion -moderate doseExperimental Treatment3 Interventions

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.

Group II: Propofol infusion - low doseActive Control3 Interventions

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.