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Slow Wave Induction by Propofol to Eliminate Depression (SWIPED)

Primary Purpose

Treatment Resistant Depression

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Propofol
Electroencephalography (EEG)
Slow-Wave Activity
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Treatment Resistant Depression

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of Medicine/Barnes-Jewish HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Propofol infusion - moderate dose

Propofol infusion - low dose

Arm Description

Serial propofol infusions to maximally and safely induce unconsciousness and EEG slow waves while minimizing burst suppression.

Serial propofol infusions to safely induce unconsciousness while minimizing EEG slow waves and burst suppression.

Outcomes

Primary Outcome Measures

Duration of Slow Wave Activity
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.

Secondary Outcome Measures

Full Information

First Posted
December 17, 2020
Last Updated
June 23, 2023
Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04680910
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2021 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Pilot Study for safety and feasibility and then randomized controlled trial.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Propofol infusion - moderate dose
Arm Type
Experimental
Arm Description
Serial propofol infusions to maximally and safely induce unconsciousness and EEG slow waves while minimizing burst suppression.
Arm Title
Propofol infusion - low dose
Arm Type
Active Comparator
Arm Description
Serial propofol infusions to safely induce unconsciousness while minimizing EEG slow waves and burst suppression.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
anesthetic
Intervention Description
Targeted propofol infusion in TRD patients will induce sedation. Dosage of propofol is determined based upon EEG markers and treatment arm.
Intervention Type
Diagnostic Test
Intervention Name(s)
Electroencephalography (EEG)
Intervention 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Slow-Wave Activity
Intervention 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.
Primary Outcome Measure Information:
Title
Duration of Slow Wave Activity
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. Delta sleep ratio will be computed from the SWA measured during the first and second N2/N3 cycles.
Time Frame
Up to 10 weeks following consent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Robeck
Phone
314-273-0901
Email
robeckmatthew@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Palanca, MD PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine/Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Robeck
Phone
314-273-0901
Email
robeckmatthew@wustl.edu
First Name & Middle Initial & Last Name & Degree
Ben Palanca, MD PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
26055669
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.
Results Reference
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PubMed Identifier
22676966
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.
Results Reference
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PubMed Identifier
27514301
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.
Results Reference
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Slow Wave Induction by Propofol to Eliminate Depression (SWIPED)

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