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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02461927
Recruitment Status : Recruiting
First Posted : June 3, 2015
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Alcohol Use Disorder Drug: Ketamine + Naltrexone Drug: Ketamine + Placebo Drug: Placebo (psychoactive placebo midazolam) + Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ketamine for The Rapid Treatment of Major Depression and Alcohol Use Disorder
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: Ketamine + Naltrexone
Subjects in this arm will receive (1) intravenous ketamine treatment once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular naltrexone once a month (a total of 2 injections).
Drug: Ketamine + Naltrexone
Subjects in this arm 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 2 injections).

Experimental: Ketamine + Placebo
Subjects in this arm will receive (1) intravenous ketamine treatment once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular placebo once a month (a total of 2 injections).
Drug: Ketamine + Placebo
Subjects in this arm will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections).

Placebo Comparator: Placebo (psychoactive placebo midazolam) + Placebo
Subjects in this arm will receive (1) intravenous placebo treatment (psychoactive placebo midazolam) once a week for 4 weeks (a total of 4 infusions) with a follow-up of 4 weeks and (2) intramuscular placebo once a month (a total of 2 injections).
Drug: Placebo (psychoactive placebo midazolam) + Placebo
Subjects in this arm will receive (1) intravenous psychoactive placebo midazolam (0.045 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections).




Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Day 21 ]
    Severity of depression

  2. Time Line Follow Back (TLFB) [ Time Frame: Day 28 ]
    Rate of complete abstinence from alcohol



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461927


Contacts
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Contact: Gihyun Yoon, MD (203) 932-5711 ext 7421 gihyun.yoon@va.gov

Locations
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United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT Recruiting
West Haven, Connecticut, United States, 06516
Contact: Gihyun Yoon, MD    203-932-5711 ext 7421    gihyun.yoon@va.gov   
Principal Investigator: Gihyun Yoon, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Gihyun Yoon, MD VA Connecticut Healthcare System West Haven Campus, West Haven, CT

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02461927    
Other Study ID Numbers: MHBB-009-16F
GY 0002 ( Other Identifier: VA Connecticut Healthcare System )
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Analytic Code

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Disease
Alcoholism
Depressive Disorder
Depression
Depressive Disorder, Major
Alcohol Drinking
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Midazolam
Naltrexone
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action