Endogenous Opioid Modulation by Ketamine

• Status: Withdrawn
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: Endorphins; Ketamine

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