Endogenous Opioid Modulation by Ketamine

Utah System of Higher Education (USHE)

Status and phase

Withdrawn

Phase 3

Conditions

Major Depressive Disorder

Treatments

Other: Normal saline

Drug: Ketamine Hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT03051945

00087544

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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