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
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Alcohol dependence (AD) and Major Depressive Disorder (MDD) are among the most frequent
      psychiatric disorders in the general population, and the co-occurrence of those disorders
      represents a significant public health problem. Levels of alcohol use have been shown to be
      associated with levels of depressive symptoms among comorbid populations. Previous medication
      trials with SSRI antidepressants in this comorbid population have produced disappointing
      results. Mirtazapine is a non-SSRI 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. Our own recent open label pilot study suggested robust
      within-group efficacy for mirtazapine for decreasing both the drinking and the depressive
      symptoms of AD/MDD subjects. 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 pilot study to provide a
      preliminary assessment of 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 study 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 versus placebo in this comorbid population.
    

Intervention name(s): Mirtazapine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Remeron
Intervention MeSH terms: Mirtazapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Alcohol Use Disorder