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Neural and Antidepressant Effects of Propofol (Phase 2)

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ClinicalTrials.gov Identifier: NCT03923361
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Brian Mickey, University of Utah

Tracking Information
First Submitted Date  ICMJE April 19, 2019
First Posted Date  ICMJE April 22, 2019
Last Update Posted Date May 29, 2019
Actual Study Start Date  ICMJE April 16, 2019
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2019)
Hamilton Rating Scale for Depression [ Time Frame: 3 weeks after baseline ]
24-item Hamilton Depression Rating Scale, total score Higher values represent more severe depressive symptoms Maximum score, 76; minimum score, 0 Remission defined as total score < 10 Response defined as decrease of total score from baseline > 50%
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
Hamilton Rating Scale for Depression [ Time Frame: 3 weeks ]
Change History Complete list of historical versions of study NCT03923361 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neural and Antidepressant Effects of Propofol (Phase 2)
Official Title  ICMJE Neural and Antidepressant Effects of Propofol (Phase 2)
Brief Summary Moderate-intensity propofol treatments will be administered to participants who are non-responders at the end of Phase 1.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Treatment Resistant Depression
Intervention  ICMJE Drug: Diprivan
Similar to the high-intensity propofol treatments in Phase 1, the anesthesiologist will administer an induction dose of propofol followed by a continuous infusion, insert an airway, and begin mechanical ventilation. Propofol dosing will be adjusted with the goal of achieving a burst-suppression state with a SR of 40-60 for 12-15 minutes.
Other Name: Propofol
Study Arms  ICMJE Experimental: Propofol
Intervention: Drug: Diprivan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2024
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18-55
  • Diagnosis of major depressive disorder or bipolar disorder
  • Current moderate-to-severe depressive episode
  • Episode duration more than 2 months and less than 5 years
  • Failure of at least 2 adequate antidepressant medication trials within the past 2 years
  • Body mass index < 40
  • 16-item Quick Inventory of Depressive Symptomatology, self-rated > 10

Exclusion Criteria:

  • Contraindication to propofol or midazolam
  • Daily use of benzodiazepine, opioid, ACE inhibitor, or ARB medication
  • Symptomatic coronary artery disease or heart failure
  • Poorly controlled hypertension or diabetes
  • Abnormal kidney or liver function
  • Pregnant or breast feeding
  • Traumatic brain injury or significant neurologic signs (past year)
  • Substance use disorder (past year)
  • Obsessive compulsive disorder (current)
  • Post-traumatic stress disorder (current)
  • Schizophrenia-spectrum disorder (lifetime)
  • Neurocognitive disorder (current)
  • Personality disorder as a current focus of treatment
  • ECT within the past 3 months
  • Inappropriate for ECT, or poor response to ECT within the past 5 years
  • Incompetent to provide consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03923361
Other Study ID Numbers  ICMJE 00116093B
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brian Mickey, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Utah
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP