Endogenous Opioid Modulation by Ketamine

Major Depressive Disorder Clinical Trial

Official title:

Endogenous Opioid Modulation by Ketamine

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03051945
• Other study ID #: 00087544
• Status: Withdrawn
• Phase: Phase 3
• Start date: August 2019
• Est. completion date: August 1, 2019

Study information

• Verified date: January 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale at 24 hours, change from baseline	total score on the 17-item Hamilton Depression Rating Scale	24 hr