Quetiapine for Bipolar Disorder and Alcohol Dependence

描述（由申请人提供）：双相情感障碍是一种严重、持续和常见的精神疾病，与酒精相关疾病的终生患病率高达46%。当双相情感障碍患者出现酒精依赖时，酒精依赖与许多不良后果相关，包括住院时间增加、住院期间预后不良、对自己和他人的暴力行为以及治疗不依从性。因此，有效治疗双相情感障碍和酒精依赖患者是一个主要的公共卫生问题。然而，到目前为止，只有一个安慰剂对照试验已报告在双相情感障碍和酒精依赖患者。在过去的8年里，我们的团队开发了一个研究项目，在双相情感障碍和物质相关障碍患者中进行临床试验。我们研究的一种特别有前途的药物是非典型抗精神病药奎替利。开放标签和 我们小组的安慰剂对照试验数据表明，奎替鲁附加治疗耐受性良好，并与双相情感障碍和酒精依赖患者的酒精使用减少和情绪改善相关。一项为期12周的随机、双盲、安慰剂对照研究，在86例患有双相I型或II型障碍、抑郁期和酒精依赖伴主动饮酒的门诊患者中进行奎替鲁附加治疗。为了反映我们地理区域的多样性，讲英语和西班牙语的与会者都将参加。每位参与者还将获得一个专门为双相情感障碍和物质依赖患者设计的手动认知行为治疗的心理社会平台。结局指标包括使用时间轴随访法、汉密尔顿抑郁量表、抑郁症状自评量表、Young躁狂量表、Penn酒精渴求量表和肝酶评估的酒精使用情况。将监测副作用。规范合并用药的管理（例如，情绪稳定剂、抗抑郁药），在绝对必要时，将使用治疗算法在两组中管理伴随药物变化。酒精使用将是主要结果，酒精渴望和情绪症状是次要结果。将探讨酒精使用变化与情绪变化之间的关系。一个在双重诊断、情绪障碍、临床试验、统计学和酒精依赖研究方面具有丰富经验的研究团队已经组建起来进行试验。

DESCRIPTION (provided by applicant): Bipolar disorder is a severe, persistent, and common psychiatric illness that is associated with a staggering 46% lifetime prevalence of alcohol-related disorders. When present in patients with bipolar disorder, alcohol dependence is associated with numerous adverse consequences including increased hospitalization, poor outcome during hospitalization, violence towards self and others, and treatment nonadherence. Thus, effective treatment of patients with bipolar and alcohol dependence is a major public health concern. However, to date, only one placebo-controlled trial has been reported in patients with bipolar disorder and alcohol dependence. Our group over the past 8 years has developed a research program that conducts clinical trials in persons with bipolar disorder and substance-related disorders. One particularly promising medication that we have investigated is the atypical antipsychotic quetiapine. Both open-label and placebo-controlled pilot data from our group suggest that quetiapine add-on therapy is well tolerated and associated with a reduction in alcohol use and improvement in mood in patients with bipolar disorder and alcohol dependence. A 12-week randomized, double-blind, placebo-controlled, study of quetiapine add-on therapy in 86 outpatients with bipolar I or II disorder, depressed phase and alcohol dependence with active alcohol use is proposed. To reflect the diversity of our geographic region, both English- and Spanish-speaking participants will be included. Each participant will also receive a psychosocial platform of manual-driven cognitive behavioral therapy specifically designed for patients with bipolar disorder and substance dependence. Outcome measures will include alcohol use assessed with the Timeline Followback method, Hamilton Rating Scale for Depression, Inventory of Depressive Symptomatology-Self-report, Young Mania Rating Scale, Penn Alcohol Craving Scale, and liver enzymes. Side effects will be monitored. To standardize management of concomitant medications (e.g., mood stabilizers, antidepressants), concomitant medication changes, when absolutely necessary, will be managed in both groups using a treatment algorithm. Alcohol use will be the primary outcome, with alcohol craving and mood symptoms as secondary outcomes. The relationship between changes in alcohol use and changes in mood will be explored. A research team with extensive experience in dual diagnosis, mood disorders, clinical trials, statistics, and alcohol dependence research has been assembled to conduct the trial.