CompletedPhase 2

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

5 participantsStarted 2016-05

Plain-language summary

To evaluate if naltrexone plus ketamine is effective in reducing depression and alcohol consumption.

Age range21 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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)

Response in symptoms of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)

Timeframe: Day 21

NCT IDNCT03658330

SponsorVA Connecticut Healthcare System

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2016-10

Who can participate

Age range21 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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)