Endogenous Opioid Modulation by Ketamine

NCT03051945 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: 00087544
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale at 24 hours, change from baseline

  total score on the 17-item Hamilton Depression Rating Scale

  24 hr

Study Arms (2)

Ketamine

EXPERIMENTAL

Ketamine will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total).

Drug: Ketamine Hydrochloride

Placebo

PLACEBO COMPARATOR

Normal saline will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total).

Other: Normal saline

Interventions

Ketamine Hydrochloride DRUG

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.

Ketamine

Normal saline OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 14, 2017
• Study Start: August 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)