Saint Louis, Missouri 63110

  • Treatment Resistant Depression

Purpose:

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).


Study summary:

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.


Criteria:

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


NCT ID:

NCT04680910


Primary Contact:

Principal Investigator
Ben Palanca, MD PhD
Washington University School of Medicine

Thomas Nguyen
Phone: 314-273-2454
Email: nguyen.t@wustl.edu


Backup Contact:

N/A


Location Contact:

Saint Louis, Missouri 63110
United States

Thomas Nguyen
Phone: 314-273-2454
Email: nguyen.t@wustl.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 28, 2022

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