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

ConditionDepression

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age60+

SponsorWashington University School of Medicine

About 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 does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Propofol
Drug
Targeted propofol infusion in TRD patients will induce sedation. Dosage of propofol is determined based upon EEG markers and treatment arm.
Electroencephalography (EEG)
Diagnostic test
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.
Brief Behavioral Therapy for Insomnia
Behavioral
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.

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: Propofol infusion -moderate doseExperimental treatment 3 interventions

Group B: Propofol infusion - low doseActive comparator 3 interventions

Trial outcomes

Primary outcomes

Change in SWS duration

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.

Time frame

Pre-infusion and on the nights of propofol infusions

Sponsors and contacts

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Washington University School of Medicine

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov

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