Major Depressive Disorder Clinical Trial
Official title:
Ketamine for The Rapid Treatment of Major Depression and Alcohol Use Disorder
Verified date | October 2023 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators will compare 3 treatment groups (ketamine plus naltrexone vs. ketamine alone vs. placebo) for treating major depressive disorder (MDD) and alcohol use disorder (AUD) in an 8-week randomized, double-blind, placebo-controlled, between-subjects trial. First, prior to the double-blind trial, the investigators will conduct an open-label trial that will include 5 patients with comorbid MDD and AUD to test safety and efficacy of repeated ketamine treatment (0.5 mg/kg; once a week for 4 weeks; a total of 4 ketamine infusions) with a follow-up of 4 weeks. Second, after reviewing the safety and efficacy of repeated ketamine treatment from the open-label trial, the investigators will conduct an 8-week, randomized, double-blind, placebo-controlled trial that will include 60 patients with comorbid MDD and AUD to test safety and efficacy of repeated ketamine treatment (0.5 mg/kg; once a week for 4 weeks; a total of 4 ketamine infusions) plus naltrexone with a follow-up of 4 weeks. The 4-month follow-up session will also occur.
Status | Completed |
Enrollment | 65 |
Est. completion date | October 30, 2023 |
Est. primary completion date | October 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | Inclusion Criteria: - Male or female veterans and civilians, 21-65 years old - Current major depressive disorder without psychotic features by DSM-5 (antidepressant regimens can be allowed and changed during the trial) - Montgomery-Asberg Depression Rating Scale (MADRS) 20 or higher - A minimum of 4 of 11 current alcohol use disorder symptoms by DSM-5 - Heavy drinking at least 4 times in the past month ('heavy drinking' defined as 5 standard drinks per day for men and 4 standard drinks per day for women - 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 dementia - Current uncontrolled hypertension (systolic BP > 170 mm Hg or diastolic BP > 100 mm Hg) - Unstable medical condition or allergy to ketamine, midazolam, 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 - Current use of benzodiazepine - Acute narrow-angle glaucoma - Severe sleep apnea---clinically determined by a physician |
Country | Name | City | State |
---|---|---|---|
United States | VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Montgomery-Asberg Depression Rating Scale (MADRS) | Severity of depression | Day 21 (after 4th infusion, 240 minutes) | |
Primary | Time Line Follow Back (TLFB) | Rate of complete abstinence from alcohol | Day 28 |
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