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

• ClinicalTrials.gov Identifier: NCT03658330
• Recruitment Status: Completed
• First Posted: September 5, 2018
• Last Update Posted: September 7, 2018
• Sponsor: VA Connecticut Healthcare System
• Information provided by (Responsible Party): Gihyun Yoon, VA Connecticut Healthcare System

Tracking Information

• First Submitted Date: September 1, 2018
• First Posted Date: September 5, 2018
• Last Update Posted Date: September 7, 2018
• Actual Study Start Date: May 2016
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 4, 2018)

Response in symptoms of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Day 21 ]

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).

Original Primary Outcome Measures (submitted: September 1, 2018)

Response (≥ 50% improvement from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) scores [ Time Frame: Day 21 ]

Severity of depression

Current Secondary Outcome Measures (submitted: September 4, 2018)

Obsessive Compulsive Drinking Scale (OCDS) [ Time Frame: Day 21 ]

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).

Original Secondary Outcome Measures (submitted: September 1, 2018)

Obsessive Compulsive Drinking Scale (OCDS) [ Time Frame: Day 21 ]

Alcohol craving and consumption

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Major Depressive Disorder
• Alcohol Use 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).

Study Arms

Experimental: 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).

Intervention: Drug: Ketamine + Naltrexone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 1, 2018): 5
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 2018
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03658330
• Other Study ID Numbers: GY0004
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Gihyun Yoon, VA Connecticut Healthcare System
• Study Sponsor: VA Connecticut Healthcare System
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gihyun Yoon, MD; VA Connecticut Healthcare System

• PRS Account: VA Connecticut Healthcare System
• Verification Date: September 2018