Endogenous Opioid Modulation by Ketamine

January 24, 2020 updated by: Brian Mickey, University of Utah
Demonstrate the acute effects of ketamine on endogenous µ-opioid neurotransmission in humans.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Depression Rating Scale at 24 hours, change from baseline
Time Frame: 24 hr
total score on the 17-item Hamilton Depression Rating Scale
24 hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2019

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

February 7, 2017

First Submitted That Met QC Criteria

February 9, 2017

First Posted (Actual)

February 14, 2017

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 24, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00087544

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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