Treatment of Young Adults With Comorbid AUD/MDD: A Pilot Medication Trial
Condition: Major Depressive Disorder; Alcohol Use Disorder
MeSH terms: Alcoholism; Depressive Disorder; Depression; Depressive Disorder, Major; Alcohol Drinking
Intervention: Mirtazapine; Placebo
Intervention description: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.; Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.
Intervention MeSH terms: Mirtazapine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Major Depressive Disorder; Alcohol Use Disorder

Summary:

      Recent reports have shown that alcohol misuse is a particularly serious problem among the 18
      to 25 year old age group. Previous medication trials with SSRI antidepressants among young
      adults with co-occurring depressive disorders, including our own recent trials with SSRI
      medications, have produced disappointing results, especially for decreasing the level of
      alcohol consumption. Mirtazapine is a non-SSRI medication with a unique structure and
      mechanism of action. Recent study results suggest that mirtazapine is more effective than
      other antidepressants for treating non-comorbid depression. A few recent studies with
      mirtazapine have been conducted among subjects with comorbid AUD/MDD, and those studies have
      demonstrated efficacy for mirtazapine for decreasing the depressive symptoms and the alcohol
      craving of subjects with comorbid AUD/MDD. However, those studies did not measure level of
      alcohol consumption, so it is unclear whether mirtazapine decreases the level of alcohol use
      of that comorbid population. The results of our own very recent open label pilot study
      suggest robust within-group efficacy for mirtazapine for decreasing both the level of alcohol
      use and the depressive symptoms of comorbid subjects. However, that pilot study did not
      include a placebo control group, so the efficacy of mirtazapine versus placebo for decreasing
      the level of alcohol use among persons with comorbid AUD/MDD remains unclear. This grant
      submission proposes to conduct a first double-blind, placebo-controlled pilot study to
      provide a preliminary assessment of the efficacy of mirtazapine versus placebo for decreasing
      both the alcohol use and depressive symptoms of young adults with comorbid AUD/MDD. If
      results (effect sizes) from the proposed study are found to be promising concerning outcome
      differences between the mirtazapine and placebo groups, then we will use those findings to
      apply for an R01 study to definitively assess the efficacy of mirtazapine for treating young
      adults with AUD/MDD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV-TR diagnosis of current alcohol dependence, confirmed by the Mini International
             Neuropsychiatric Interview (MINI)

          -  DSM-IV-TR diagnosis of current major depressive disorder, confirmed by the Mini
             International Neuropsychiatric Interview (MINI)

        Exclusion Criteria:

          -  Any person who meets criteria for alcohol-induced depression

          -  Any psychotic disorder bipolar disorder, mental retardation, impaired cognitive
             functioning, or use of any psychotropic medication in the previous month

          -  Current Diagnostic and Statistical Manual (DSM-IV) criteria for dependence on
             substances other than alcohol, cannabis, nicotine, or caffeine

          -  Significant neurological conditions or medical conditions

          -  Persistent elevation of liver function enzymes indicating active liver disease
             (elevated t. bilirubin or elevation to three-time normal range of liver enzymes, SGOT,
             SGPT, or g-GTP)

          -  The presence of renal function impairment defined as serum creatinine >2x upper limit
             of normal

          -  Pregnancy, inability or unwillingness to use contraceptive methods

          -  Use of any antidepressant medication in the prior two months, or any lifetime use of
             mirtazapine

          -  Inability to read or understand study forms and agree to informed consent