Phase 1
Completed N=16
Slow Wave Induction by Propofol to Eliminate Depression (SWIPED) I
Source: ClinicalTrials.gov NCT04680910 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: Number of Participants Without Serious Adverse Events During Propofol Infusions — 16 Participants
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Without Serious Adverse Events During Propofol Infusions |
16 | — |
| PRIMARY Change in SWA During Propofol Infusions Compared to Awake Baseline Before Infusion |
18.6 | — |
| PRIMARY Proportion of Infusion Completers With Augmentation of Sleep SWA After Propofol Infusion |
6 | — |
| SECONDARY Effects on Suicidality |
1; 0; 0; 0 | — |
| SECONDARY Changes in N3 Duration, REM Duration, Total Sleep Time (Post-infusion Change Relative to Baseline) |
17.75; 4; -5.75 | — |
| SECONDARY Change in Delta Sleep Ratio (Infusion Nights - Baseline) |
0.075 | — |
| SECONDARY Changes in Proportion of Total Sleep Time in N3, Proportion of Total Sleep Time in REM |
4.5; 2.7 | — |
| SECONDARY Evaluate Changes in Cognitive Function (MoCA) Between Pre-infusion Baseline and 3-weeks Post Infusion |
0.14 | — |
| SECONDARY Number of Participants Able to Provide Complete Cognitive Assessment (Fluid Cognition) Using NIH Toolbox |
8 | — |
Eligibility Criteria
Inclusion 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)
- Treatment-resistant Depression (non-responsive to at least two adequate trials of oral antidepressants for current episode).
Exclusion Criteria
- Presence of symptomatic coronary artery disease
- Presence of marked congestive heart failure/cardiomyopathy (NYHA > Class III, LVEF 35
- C-SSRS of 4 or greater (active suicidal ideation with some intent and with/without a specific plan)
- MoCA score 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.
Data sourced from ClinicalTrials.gov (NCT04680910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.