Endogenous Opioid Modulation by Ketamine

Brief Summary

Demonstrate the acute effects of ketamine on endogenous µ-opioid neurotransmission in humans.

Intervention / Treatment

  • Ketamine Hydrochloride (DRUG)
    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.
  • Normal saline (OTHER)
    Placebo

Condition or Disease

  • Major Depressive Disorder

Phase

  • Phase 3
  • Study Design

    Study type: INTERVENTIONAL
    Status: Withdrawn
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 0 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Basic Science

    Masking

    DOUBLE:
    • Participant
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Aug 01, 2019 ESTIMATED
    Primary Completion: Aug 01, 2019 ACTUAL
    Completion Date: Aug 01, 2019 ACTUAL
    Study First Posted: Feb 14, 2017 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Jan 24, 2020

    Sponsors / Collaborators

    Lead Sponsor: University of Utah
    Responsible Party: N/A

    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.

    Participant Groups

    • Ketamine will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total).

    • Normal saline will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total).

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • total score on the 17-item Hamilton Depression Rating Scale

    More Details

    NCT Number: NCT03051945
    Other IDs: 00087544
    Study URL: https://clinicaltrials.gov/study/NCT03051945
    Last updated: Sep 29, 2023