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Endogenous Opioid Modulation by Ketamine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (Unable to perform brain imaging)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

Study Description
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Brief Summary:
Demonstrate the acute effects of ketamine on endogenous µ-opioid neurotransmission in humans.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Ketamine Hydrochloride Other: Normal saline Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Endogenous Opioid Modulation by Ketamine
Estimated Study Start Date : August 2019
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : August 1, 2019

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Arms and Interventions
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Arm Intervention/treatment
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).
 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.
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).
 Other: Normal saline
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Hamilton Depression Rating Scale at 24 hours, change from baseline [ Time Frame: 24 hr ]
    total score on the 17-item Hamilton Depression Rating Scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT03051945


Locations
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United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
More Information
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Responsible Party: Brian Mickey, Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT03051945    
Other Study ID Numbers: 00087544
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action