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Endogenous Opioid Modulation by Ketamine

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ClinicalTrials.gov Identifier: NCT03051945
Recruitment Status : Withdrawn (Unable to perform brain imaging)
First Posted : February 14, 2017
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Brian Mickey, University of Utah

Tracking Information
First Submitted Date  ICMJE February 7, 2017
First Posted Date  ICMJE February 14, 2017
Last Update Posted Date January 28, 2020
Estimated Study Start Date  ICMJE August 2019
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
Hamilton Depression Rating Scale at 24 hours, change from baseline [ Time Frame: 24 hr ]
total score on the 17-item Hamilton Depression Rating Scale
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
Montgomery Asberg Depression Rating Scale at 24 hr, change from baseline [ Time Frame: 24 hr ]
Change History
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 Endogenous Opioid Modulation by Ketamine
Official Title  ICMJE Endogenous Opioid Modulation by Ketamine
Brief Summary Demonstrate the acute effects of ketamine on endogenous µ-opioid neurotransmission in humans.
Detailed Description This study will test the hypothesis that the rapidly-acting antidepressant ketamine improves core depressive symptoms by acutely activating the brain's endogenous µ-opioid system.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Ketamine Hydrochloride
    Study drug will be infused while the participant sits or lies in a comfortable position. The dose of ketamine used does not cause unconsciousness but may cause perceptual disturbances.
  • Other: Normal saline
    Placebo
Study Arms  ICMJE
  • Experimental: Ketamine
    Ketamine will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total).
    Intervention: Drug: Ketamine Hydrochloride
  • Placebo Comparator: Placebo
    Normal saline will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total).
    Intervention: Other: Normal saline
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 24, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2017)
40
Actual Study Completion Date  ICMJE August 1, 2019
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18-65
  • DSM-5 major depressive disorder
  • Current moderate-to-severe, treatment-resistant, depressive episode
  • Patient Health Questionnaire (PHQ-9) total score ≥ 10
  • PHQ-9 item score ≥ 2 on "Little interest or pleasure" item
  • PHQ-9 item score ≥ 2 on "Feeling down, depressed, or hopeless" item
  • Medical documentation of depression for at least 2 months
  • Inadequate response to at least one adequate antidepressant medication trial in the current episode

Exclusion Criteria:

  • Current episode duration >5 years
  • Moderate-to-severe DSM-5 substance use disorder (past year)
  • Cognitive disorder (past year)
  • Post-traumatic stress disorder (past year)
  • Obsessive compulsive disorder (past year)
  • Personality disorder (past year)
  • Positive urine drug screen
  • Psychotic symptoms
  • Mania
  • Significant neurologic disorder or injury
  • Breastfeeding or pregnancy
  • Imminent suicide risk
  • Current use of CYP3A4 inhibitors (e.g., ketoconazole or erythromycin)
  • Other unstable psychiatric or medical condition requiring a higher level of care
  • Contraindication to ketamine, MRI, or PET
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03051945
Other Study ID Numbers  ICMJE 00087544
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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 January 2020

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