Naltrexone Plus Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder

NCT03658330 | Completed Phase 2

• 1 other identifier: GY0004
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate if naltrexone plus ketamine is effective in reducing depression and alcohol consumption.

Conditions

Major Depressive Disorder; Alcohol Use Disorder

Keywords

Ketamine; Naltrexone; Depression; Alcohol

Outcome Measures

Primary Outcomes (1)

• Response in symptoms of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)

  Response is defined as a ≥ 50% improvement from baseline in MADRS scores. The MADRS has a total range of 0-60. Higher scores represent a worse outcome (i.e., more depression).

  Day 21

Secondary Outcomes (1)

• Obsessive Compulsive Drinking Scale (OCDS)

  Day 21

Study Arms (1)

Ketamine + Naltrexone

EXPERIMENTAL

Subjects will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular naltrexone (380 mg) once a month (a total of 1 injection).

Drug: Ketamine + Naltrexone

Interventions

Ketamine + Naltrexone DRUG

Subjects will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular naltrexone (380 mg) once a month (a total of 1 injection).

Ketamine + Naltrexone

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 21-65 years old
• Current major depressive disorder without psychotic features by DSM-5
• Montgomery-Åsberg Depression Rating Scale (MADRS) ≥ 20
• Current alcohol use disorder by DSM-5
• Heavy drinking at least 3 times in the past month ('heavy drinking' defined as ≥ 5 standard drinks per day for men and ≥ 4 standard drinks per day for women)
• Abstinence from alcohol drinking for \> 5 days prior to ketamine infusion
• Able to provide written informed consent

You may not qualify if:

• Current substance use disorder by DSM-5 in the past 3 months (except alcohol, tobacco, or cannabis)
• Current or past history of psychotic features or psychotic disorder
• Current or past history of delirium or dementia
• Current uncontrolled hypertension (systolic BP \> 170 mm Hg or diastolic BP \> 100 mm Hg)
• Unstable medical condition or allergy to ketamine, naltrexone, or lorazepam---clinically determined by a physician
• Imminent suicidal or homicidal risk
• Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential
• Positive opioid or illicit drug screen test (except marijuana)
• Opioid use within 10 days prior to study medication (injectable naltrexone) or risks for opioid use during the study
• Liver enzymes that are three times higher than the upper limit of normal

Sponsors & Collaborators

• VA Connecticut Healthcare System: lead

MeSH Terms

Conditions

Depressive Disorder, Major; Alcoholism; Depression

Interventions

Ketamine; Naltrexone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Gihyun Yoon, MD

  VA Connecticut Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2018
• First Posted: September 5, 2018
• Study Start: May 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: June 1, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09