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

Description

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

Depression

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Depression
Intervention / Treatment

-

Contacts and Locations

Saint Louis

Washington University School of Medicine/Barnes-Jewish Hospital, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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)
  • * Depression (non-responsive to at least one adequate trial of oral antidepressants for current episode).
  • * 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
  • * Treatment with Electroconvulsive therapy/Transcranial Magnetic Stimulation/vagal nerve stimulation within 6 weeks
  • * Body mass index \> 35
  • * C-SSRS of 4 or greater (active suicidal ideation with some intent and with/without a specific plan)
  • * MoCA score \< 23 (at least mild dementia)
  • * Schizophrenia
  • * Bipolar disorder
  • * Non-prescribed use of amphetamines, opioids, cocaine, or phencyclidine; Urine THC \> 150 ng/ml
  • * Intake of \> 14 beers/week (or equivalent)
  • * Anesthetic exposure in the past 4 weeks
  • * Concurrent use of benzodiazepines \> 2 mg/day lorazepam or equivalent, trazodone \> 50 mg/day, or gabapentin \> 600mg/day.

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Washington University School of Medicine,

Ben Palanca, MD PhD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

2028-04-01