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ACTIVE NOT RECRUITING
NCT04680910
PHASE1

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

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

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.

Official title: Precision Targeting of Propofol-induced Electroencephalographic Slow Waves: a Novel Phase I Paradigm for Treatment-resistant Major Depressive Disorder

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2021-01-14

Completion Date

2025-07-01

Last Updated

2024-12-02

Healthy Volunteers

No

Interventions

DRUG

Propofol

Targeted propofol infusion in TRD patients will induce sedation with maximal expression of EEG slow waves and minimal burst suppression.

DIAGNOSTIC_TEST

Electroencephalography (EEG)

EEG will be recorded during propofol infusion and during overnight sleep. Sleep EEG data will be acquired for a minimum of one night prior to the first sedation session, providing a baseline measure. Additional overnight sleep recordings will be performed on day of sedation and subsequent nights.

DIAGNOSTIC_TEST

Slow-Wave Activity

Duration of slow waves during sedation will be evaluated using automated approaches. SWA during sedation will be calculated as the total power in the 0.5-4 Hz frequency band/total time in minutes. SWA during N2/N3 sleep will be calculated as the total power in the 0.5-4 Hz frequency band/total time in minutes in the N2 and N3 sleep stages. Delta sleep ratio will be computed from the SWA measured during the first and second N2/N3 cycles.

Locations (1)

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, United States