RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-03-04
Study Completion:2028-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06867549

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.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study
  3. * Age 60 or greater
  4. * 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)
  5. * Depression (non-responsive to at least one adequate trial of oral antidepressants for current episode).
  1. * Presence of symptomatic coronary artery disease
  2. * Presence of marked congestive heart failure/cardiomyopathy(NYHA \> Class III, LVEF \<40%, greater than mild RV systolic dysfunction)
  3. * Prior reaction to propofol
  4. * Resting heart rate \< 50 bpm
  5. * Treatment with Electroconvulsive therapy/Transcranial Magnetic Stimulation/vagal nerve stimulation within 6 weeks
  6. * Body mass index \> 35
  7. * C-SSRS of 4 or greater (active suicidal ideation with some intent and with/without a specific plan)
  8. * MoCA score \< 23 (at least mild dementia)
  9. * Schizophrenia
  10. * Bipolar disorder
  11. * Non-prescribed use of amphetamines, opioids, cocaine, or phencyclidine; Urine THC \> 150 ng/ml
  12. * Intake of \> 14 beers/week (or equivalent)
  13. * Anesthetic exposure in the past 4 weeks
  14. * Concurrent use of benzodiazepines \> 2 mg/day lorazepam or equivalent, trazodone \> 50 mg/day, or gabapentin \> 600mg/day.

Contacts and Locations

Study Contact

Sarah E Knarr
CONTACT
314-362-2415
knarr.sarah@wustl.edu

Principal Investigator

Ben Palanca, MD PhD
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Washington University School of Medicine

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-04
Study Completion Date2028-04-01

Study Record Updates

Study Start Date2025-03-04
Study Completion Date2028-04-01

Terms related to this study

Additional Relevant MeSH Terms

  • Depression