Propofol + Therapy for Depression

(SWIPED II Trial)

Overseen By Sarah E Knarr

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Must be taking: Antidepressants

Must not be taking: Benzodiazepines, Trazodone, Gabapentin

Disqualifiers: Coronary artery disease, Heart failure, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 1-2 weeks

70 Participants Needed

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.

Research Team

Ben Palanca, MD PhD

Principal Investigator

Washington University School of Medicine

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.

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

Prior reaction to propofol

Resting heart rate < 50 bpm

C-SSRS of 4 or greater (active suicidal ideation with some intent and with/without a specific plan)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Behavioral Therapy

Two sessions of Brief Behavioral Therapy for Insomnia (BBTI) are administered before the propofol infusions

1-2 weeks

2 visits (in-person or virtual)

Treatment

Participants receive two propofol infusions, 2-6 days apart, with concurrent EEG monitoring

1-2 weeks

2 visits (in-person)

Post-Treatment Behavioral Therapy

Two additional sessions of BBTI are administered within 6 weeks after the second infusion

6 weeks

2 visits (in-person or virtual)

Follow-up

Participants are monitored for changes in sleep structure, cognition, anhedonia, and depression up to 10 weeks after the second infusion

10 weeks

Overnight sleep recordings and cognitive assessments

Treatment Details

Interventions

• Propofol

Trial Overview 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.

Participant Groups

Group I: Propofol infusion -moderate dose Experimental Treatment 3 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 dose Active Control 3 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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+