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

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

Study is Available At:

Original ID:

202008037

NCT ID:

NCT04680910

Secondary ID:

Study Acronym:

Brief Title:

Slow Wave Induction by Propofol to Eliminate Depression (SWIPED)

Official Title:

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

ClinicalTrials.gov Link:

https://clinicaltrials.gov/show/NCT04680910

Overall Status:

Recruiting

Study Phase:

Phase 1/Phase 2

Genders:

N/A

Minimum Age:

60 Years

Maximum Age:

N/A

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Washington University School of Medicine

Oversight Authority:

There was an error processing this request

Reasons Why Stopped:

Study Type:

Interventional

Study Design:

Number of Arms:

Number of Groups:

Total Enrollment:

Enrollment Type:

Anticipated

Overall Contact Information

Official Name:	Ben Palanca, MD PhD Principal Investigator Washington University School of Medicine
Primary Contact:	Thomas Nguyen 314-273-2454 nguyen.t@wustl.edu

Study Dates

Start Date:	January 14, 2021
Completion Date:	December 1, 2026
Completion Type:	Anticipated
Primary Completion Date:	December 1, 2025
Primary Completion Type:	Anticipated
Verification Date:	January 2022
Last Changed Date:	January 7, 2022
First Received Date:	December 17, 2020

Study Outcomes

Outcome Type:	Primary Outcome
Measure:	Duration of Slow Wave Activity
Time Frame:	Up to 10 weeks following consent
Safety Issues:	False
Description:	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

Study Interventions

Intervention Type:	Diagnostic Test
Name:	Slow-Wave Activity
Description:	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.
Arm Name:	Propofol infusion - low dose
Intervention Type:	Diagnostic Test
Name:	Electroencephalography (EEG)
Description:	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.
Arm Name:	Propofol infusion - low dose
Intervention Type:	Drug
Name:	Propofol
Description:	Targeted propofol infusion in TRD patients will induce sedation. Dosage of propofol is determined based upon EEG markers and treatment arm.
Arm Name:	Propofol infusion - low dose
Other Name:	anesthetic

Study Arms

Study Arm Type:	Experimental
Arm Name:	Propofol infusion - moderate dose
Description:	Serial propofol infusions to maximally and safely induce unconsciousness and EEG slow waves while minimizing burst suppression.
Study Arm Type:	Active Comparator
Arm Name:	Propofol infusion - low dose
Description:	Serial propofol infusions to safely induce unconsciousness while minimizing EEG slow waves and burst suppression.

Study Agencies

Agency Class:	Other
Agency Type:	Lead Sponsor
Agency Name:	Washington University School of Medicine
Agency Class:	NIH
Agency Type:	Collaborator
Agency Name:	National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study Links

There are no available Study Links

Study References

Reference Type:	Reference
Citation:	Murphy MJ, Peterson MJ. Sleep Disturbances in Depression. Sleep Med Clin. 2015 Mar;10(1):17-23. doi: 10.1016/j.jsmc.2014.11.009. Epub 2014 Dec 12. Review.
PMID:	26055669
Reference Type:	Reference
Citation:	Duncan WC, Sarasso S, Ferrarelli F, Selter J, Riedner BA, Hejazi NS, Yuan P, Brutsche N, Manji HK, Tononi G, Zarate CA. Concomitant BDNF and sleep slow wave changes indicate ketamine-induced plasticity in major depressive disorder. Int J Neuropsychopharmacol. 2013 Mar;16(2):301-11. doi: 10.1017/S1461145712000545. Epub 2012 Jun 7.
PMID:	22676966
Reference Type:	Reference
Citation:	Doghramji K, Jangro WC. Adverse Effects of Psychotropic Medications on Sleep. Psychiatr Clin North Am. 2016 Sep;39(3):487-502. doi: 10.1016/j.psc.2016.04.009. Epub 2016 Jun 24. Review.
PMID:	27514301

Data Source: ClinicalTrials.gov

Date Processed: August 16, 2022

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

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Purpose:

Study summary:

Criteria:

Study is Available At:

Original ID:

NCT ID:

Secondary ID:

Study Acronym:

Brief Title:

Official Title:

ClinicalTrials.gov Link:

Overall Status:

Study Phase:

Genders:

Minimum Age:

Maximum Age:

Quick Facts

Study Source:

Oversight Authority:

Reasons Why Stopped:

Study Type:

Study Design:

Number of Arms:

Number of Groups:

Total Enrollment:

Enrollment Type:

Overall Contact Information

Study Dates

Study Outcomes

Study Interventions

Study Arms

Study Agencies

Sample and Retention Information

There are no available Sample and Retention Information

Study Links

There are no available Study Links

Study References

Data Source: ClinicalTrials.gov

Date Processed: August 16, 2022

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

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