Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD), Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 1/3/2019 |
| Start Date: | January 1, 2015 |
| End Date: | June 30, 2021 |
| Contact: | Gihyun Yoon, MD |
| Email: | gihyun.yoon@va.gov |
| Phone: | (203) 932-5711 |
Ketamine for The Rapid Treatment of Major Depression and Alcohol Use Disorder
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.
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.
Inclusion Criteria:
- 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
We found this trial at
1
site
West Haven, Connecticut 06516
Principal Investigator: Gihyun Yoon, MD
Phone: 203-932-5711
Click here to add this to my saved trials
