Endogenous Opioid Modulation by Ketamine

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03051945

Enrollment

Registered

2017-02-14

Start date

2019-08-31

Completion date

2019-08-01

Last updated

2020-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Brief summary

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

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.

Interventions

DRUGKetamine 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.

OTHERNormal saline

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026