Double-blind Pilot Trial of Mirtazapine for the Treatment of Co-occurring AD/MDD.
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: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Alcohol Use Disorder

Summary:

      Mirtazapine is a non-SSRI (selective serotonin reuptake inhibitor) medication with a unique
      structure and mechanism of action. Recent study results suggest that mirtazapine may be more
      effective and faster acting than other antidepressants. Levels of alcohol use have been shown
      to be associated with levels of depressive symptoms among comorbid populations. Our own
      recent open label pilot study suggested robust within-group efficacy for mirtazapine for
      decreasing both the drinking and the depressive symptoms of persons with co-occurring alcohol
      dependence/major depressive disorder (AD/MDD). However, no placebo control group was employed
      in that study, so between-group efficacy versus placebo could not be assessed. The current
      grant submission proposes to conduct a first double-blind, placebo-controlled study to
      evaluate the efficacy of mirtazapine versus placebo for decreasing the alcohol use and
      depressive symptoms of persons with comorbid AD/MDD. If the results of this proposed
      double-blind pilot trial are promising, then the effect sizes found in this proposed study
      will be used to help design an adequately-powered R01 treatment trial to definitively test
      the efficacy of mirtazapine in this comorbid population.
    

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