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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 : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Brian Mickey, University of Utah

Brief Summary:
Moderate-intensity propofol treatments will be administered to participants who are non-responders at the end of Phase 1.

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Drug: Diprivan Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neural and Antidepressant Effects of Propofol (Phase 2)
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
Drug Information available for: Propofol

Arm Intervention/treatment
Experimental: Propofol 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




Primary Outcome Measures :
  1. 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%



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923361


Locations
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United States, Utah
Univeristy Neuropsychiatric Institute Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Kolby Leonardi    801-587-7382    kolby.leonardi@hsc.utah.edu   
Sponsors and Collaborators
University of Utah

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Responsible Party: Brian Mickey, Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT03923361     History of Changes
Other Study ID Numbers: 00116093B
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Depressive Disorder, Treatment-Resistant
Depressive Disorder
Mood Disorders
Mental Disorders
Propofol
Antidepressive Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Psychotropic Drugs