CompletedPhase 1

Slow Wave Induction by Propofol to Eliminate Depression (SWIPED) I

United States16 participantsStarted 2021-01-14

Plain-language 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.

Who can participate

Age range60 Years

SexALL

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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 \<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.

What they're measuring

Number of Participants Without Serious Adverse Events During Propofol Infusions

Timeframe: Up to one week after propofol infusions

Change in SWA During Propofol Infusions Compared to Awake Baseline Before Infusion

Timeframe: During two-hour propofol infusion

Proportion of Infusion Completers With Augmentation of Sleep SWA After Propofol Infusion

Timeframe: Over three-week period of pre- and post-infusion sleep recordings

Trial details

NCT IDNCT04680910

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-01

Results submitted2025-09-22

View on ClinicalTrials.gov More Treatment-resistant Depression trials