Back to resultsNaltrexone Plus Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder
Primary Purpose
Major Depressive Disorder, Alcohol Use Disorder
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ketamine + Naltrexone
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Ketamine, Naltrexone, Depression, Alcohol
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ketamine + Naltrexone
Arm Description
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).
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT03658330
First Posted
September 1, 2018
Last Updated
September 5, 2018
Sponsor
VA Connecticut Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT03658330
Brief Title
Naltrexone Plus Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder
Official Title
Naltrexone Plus Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Connecticut Healthcare System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate if naltrexone plus ketamine is effective in reducing depression and alcohol consumption.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Alcohol Use Disorder
Keywords
Ketamine, Naltrexone, Depression, Alcohol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketamine + Naltrexone
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Ketamine + Naltrexone
Intervention Description
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).
Primary Outcome Measure Information:
Title
Response in symptoms of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)
Description
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).
Time Frame
Day 21
Secondary Outcome Measure Information:
Title
Obsessive Compulsive Drinking Scale (OCDS)
Description
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).
Time Frame
Day 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gihyun Yoon, MD
Organizational Affiliation
VA Connecticut Healthcare System
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Naltrexone Plus Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder
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