Endogenous Opioid Modulation by Ketamine

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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

Key facts

Study ID

NCT03051945

Run by

University of Utah

People needed

0

Starts

2019-08-01

Expected to finish

2019-08-01

Last updated by the study team

2020-01-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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