Precision Targeting of Propofol-induced Electroencephalographic Slow Waves: a Novel Phase I/2 Paradigm for Treatment-resistant Major Depressive Disorder

  • STATUS
    Recruiting
  • End date
    Dec 1, 2026
  • participants needed
    85
  • sponsor
    Washington University School of Medicine
Updated on 14 October 2022

Summary

Our overall hypothesis is that sleep slow-wave potentiation by propofol is a therapeutic pathway for enhancing slow wave sleep and alleviating treatment-resistant depression (TRD).

Description

Aim 1: Establish the safety and feasibility of multiple propofol infusions targeting of electroencephalographic (EEG) slow-wave activity (SWA) without burst suppression in geriatric patients with treatment-resistant depression (TRD) patients.

Aim 2: Compare sleep EEG SWA in geriatric patients with treatment-resistant depression (TRD) patients randomized to two arms: 1) multiple moderate-dose propofol infusions targeting of unconsciousness and electroencephalographic (EEG) slow-wave activity (SWA) without burst suppression vs 2) multiple low-dose propofol infusions targeting unconsciousness with minimal electroencephalographic (EEG) slow-wave activity (SWA) or burst suppression.

Details
Condition Treatment Resistant Depression
Treatment Propofol, Electroencephalography (EEG), Electroencephalographic (EEG), Phase I: Propofol infusion - moderate dose, Slow-Wave Activity
Clinical Study IdentifierNCT04680910
SponsorWashington University School of Medicine
Last Modified on14 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age of at least 60 years
History of Treatment-Resistant Major Depressive Disorder (defined as non-responsiveness to at least two adequate trials of oral antidepressant medications)
English Speaking

Exclusion Criteria

Symptomatic coronary artery disease
Symptomatic congestive heart failure/cardiomyopathy (New York Heart Association > Class III or left ventricular ejection fraction < 40%)
Allergy to Propofol
Resting Bradycardia
Current treatment with ECT/TMS
Active vagal nerve implantation
BMI > 35
Columbia-Suicide Severity Rating Scale (C-SSRS) of 4 or greater
Montreal Cognitive Assessment (MOCA) score < 23
Clear my responses

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