Double-blind pilot trial of mirtazapine for the treatment of co-occurring AD/MDD

描述（由申请人提供）：本提案是根据PA-10-252标题为“酒精使用障碍和抑郁/焦虑障碍（R21）的治疗"编写的。 酒精依赖（AD）和重度抑郁症（MDD）是普通人群中最常见的精神疾病之一，这些疾病的共同发生代表了一个重大的公共卫生问题。酒精使用水平已被证明与共病人群中的抑郁症状水平相关。以前在这一共病人群中使用SSRI抗抑郁药的药物试验产生了令人失望的结果。米氮平是一种非SSRI药物，具有独特的结构和作用机制。最近的研究结果表明，米氮平可能比其他抗抑郁药更有效，作用更快。我们自己最近的开放标签初步研究表明，米氮平在减少AD/MDD受试者的饮酒和抑郁症状方面具有强大的组内疗效。然而，该研究中未使用安慰剂对照组，因此无法评估与安慰剂相比的组间疗效。目前的拨款申请建议进行第一项双盲、安慰剂对照的试点研究，以初步评估米氮平与安慰剂相比在减少AD/MDD共病患者饮酒和抑郁症状方面的疗效。如果这项拟议的双盲初步研究的结果是有希望的，那么这项拟议研究中发现的效应量将用于 帮助设计一个有充分把握度的R 01治疗试验，以明确测试米氮平与安慰剂在该共病人群中的疗效。

DESCRIPTION (provided by applicant): This proposal is written in response to PA-10-252 entitled, "Treatment of Co-Occurring Alcohol Use Disorders and Depression/Anxiety Disorders (R21)". 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.