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

米氮平治疗同时发生的 AD/MDD 的双盲试点试验

• 批准号: 8620304
• 负责人: JACK R CORNELIUS
• 金额: $ 18.14万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-26 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8620304
• 关键词: Abstinence; Acute; Adverse effects; Alcohol consumption; Alcohol dependence; Antidepressive Agents; Anxiety Disorders; Applications Grants; Behavior Therapy; Cognitive Therapy; Control Groups; Data; Disease; Disease remission; Double-Blind Method; FDA approved; General Population; Grant; Heavy Drinking; Individual; Major Depressive Disorder; Mediating; Mediator of activation protein; Mental Depression; Mental disorders; Mirtazapine; Outcome; Persons; Pharmaceutical Preparations; Pharmacological Treatment; Phase; Pilot Projects; Placebo Control; Placebos; Population; Public Health; Randomized; Reporting; Safety; Selective Serotonin Reuptake Inhibitor; Severities; Structure; Therapeutic; Treatment outcome; United States National Institutes of Health; Writing; alcohol abuse therapy; alcohol use disorder; base; depressive symptoms; design; drinking; efficacy testing; improved; innovation; motivational enhancement therapy; open label; pilot trial; placebo controlled study; public health relevance; response; treatment response; treatment trial

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.

描述（由申请人提供）：本提案是针对题为“同时发生的酒精使用障碍和抑郁/焦虑障碍 (R21) 的治疗”的 PA-10-252 的回应而编写的。 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，这些疾病的同时发生代表了一个重大的公共卫生问题。饮酒水平已被证明与共病人群的抑郁症状水平相关。之前针对该共病人群使用 SSRI 抗抑郁药进行的药物试验结果令人失望。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且起效更快。我们最近的开放标签试点研究表明，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，该研究中没有采用安慰剂对照组，因此无法评估组间疗效与安慰剂的比较。目前提交的拨款提议进行第一项双盲、安慰剂对照试点研究，以初步评估米氮平与安慰剂相比，在减少 AD/MDD 共病患者的饮酒和抑郁症状方面的功效。如果这项拟议的双盲试点研究的结果是有希望的，那么这项拟议研究中发现的效应大小将用于 帮助设计一个足够有力的 R01 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。