Status:
ACTIVE_NOT_RECRUITING
Slow Wave Induction by Propofol to Eliminate Depression (SWIPED) I
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Treatment-resistant Depression
Eligibility:
All Genders
60+ years
Phase:
PHASE1
Brief Summary
Our hypothesis is that targeted propofol infusion in treatment-resistant depressed patients will induce slow wave activity during sedation and augment subsequent sleep slow wave activity. We will recr...
Detailed Description
Treatment-resistant depression (TRD) in older adults is a leading cause of disability, excess mortality from suicide, and dementia. Cognitive problems and sleep disturbances are common, contributing t...
Eligibility Criteria
Inclusion
- 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)
- Treatment-resistant Depression (non-responsive to at least two adequate trials of oral antidepressants for current episode).
Exclusion
- 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)
- Non-prescribed used of amphetamines, opioids, marijuana, cocaine, or phencyclidine
- 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 \> 600 mg/day.
Key Trial Info
Start Date :
January 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04680910
Start Date
January 14 2021
End Date
July 1 2025
Last Update
December 2 2024
Active Locations (1)
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1
Washington University School of Medicine/Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110