NCT04680910CompletedPhase 1
Slow Wave Induction by Propofol to Eliminate Depression (SWIPED) I
Precision Targeting of Propofol-induced Electroencephalographic Slow Waves: a Novel Phase I Paradigm for Treatment-resistant Major Depressive Disorder
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
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 recruit 15 participants for this open label single arm Phase I trial. All participants will undergo two propofol infusions 2-6 days apart, with each infusion maximizing expression of EEG slow waves. 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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 17 Dec 2020
- Start date
- 14 Jan 2021
- Primary completion date
- 1 Jul 2024
- Lead sponsor
- Washington University School of Medicine
- Diseases
- Depression
- NCT number
- NCT04680910
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 16
- From 14 Jan 2021 to the primary completion date, 1 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior reaction to propofol
- Treatment with Electroconvulsive therapy/Transcranial Magnetic Stimulation/vagal nerve stimulation within 6 weeks
- Concurrent use of benzodiazepines \> 2 mg/day lorazepam or equivalent, trazodone \> 50 mg/day, or gabapentin \> 600 mg/day.
Other illness
- Presence of symptomatic coronary artery disease
- Resting heart rate \< 50 bpm
- MoCA score \< 23 (at least mild dementia)
Lab values
- Presence of marked congestive heart failure/cardiomyopathy (NYHA \> Class III, LVEF \<40%, greater than mild RV systolic dysfunction)
Other
- Body mass index \> 35
- C-SSRS of 4 or greater (active suicidal ideation with some intent and with/without a specific plan)
- Non-prescribed used of amphetamines, opioids, marijuana, cocaine, or phencyclidine
- Intake of \> 14 beers/week (or equivalent)
- Anesthetic exposure in the past 4 weeks
Who the study is looking for
- 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).
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University School of Medicine/Barnes-Jewish Hospital Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.