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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03658330
• Other study ID #: GY0004
• Status: Completed
• Phase: Phase 2
• Start date: May 2016
• Est. completion date: June 2018

Study information

• Verified date: September 2018
• Source: VA Connecticut Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The primary goal of this proposal is to test naltrexone plus repeated ketamine treatment for major depressive disorder and alcohol use disorder in an open-label trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 2018
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male or female, 21-65 years old

2. Current major depressive disorder without psychotic features by DSM-5

3. Montgomery-Åsberg Depression Rating Scale (MADRS) = 20

4. Current alcohol use disorder by DSM-5

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)

6. Abstinence from alcohol drinking for > 5 days prior to ketamine infusion

7. Able to provide written informed consent

Exclusion Criteria:

1. Current substance use disorder by DSM-5 in the past 3 months (except alcohol, tobacco, or cannabis)

2. Current or past history of psychotic features or psychotic disorder

3. Current or past history of delirium or dementia

4. Current uncontrolled hypertension (systolic BP > 170 mm Hg or diastolic BP > 100 mm Hg)

5. Unstable medical condition or allergy to ketamine, naltrexone, or lorazepam---clinically determined by a physician

6. Imminent suicidal or homicidal risk

7. Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential

8. Positive opioid or illicit drug screen test (except marijuana)

9. Opioid use within 10 days prior to study medication (injectable naltrexone) or risks for opioid use during the study

10. Liver enzymes that are three times higher than the upper limit of normal

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• Ketamine + Naltrexone
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
VA Connecticut Healthcare System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Obsessive Compulsive Drinking Scale (OCDS)	The Obsessive Compulsive Drinking Scale is designed to assess alcohol craving and consumption. The scale has a total score range of 0-56. Higher scores represent a worse outcome (i.e., more alcohol problems).	Day 21