Topiramate treatment of alcohol dependence in patients with bipolar disorder

托吡酯治疗双相情感障碍患者的酒精依赖

• 批准号: 7477787
• 负责人: Michael Joshua Ostacher
• 金额: $ 22.09万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-08-01 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7477787
• 关键词: Adherence; Adult; Adverse effects; Alcohol abuse; Alcohol consumption; Alcohol dependence; Alcohols; Area; Award; Biometry; Bipolar Disorder; Boston; Caring; Clinic; Clinical; Clinical Trials Design; Condition; Conduct Clinical Trials; Consultations; DSM-IV; Data; Disease; Dropout; Drug abuse; End Point; Enrollment; General Hospitals; Goals; Health Services Research; Heavy Drinking; Hospitals; Incidence; Massachusetts; Measures; Mentors; Mood Disorders; Moods; National Institute of Mental Health; Numbers; Outcome; Patients; Pharmaceutical Preparations; Placebos; Population; Publishing; Purpose; Randomized; Randomized Controlled Trials; Rate; Reporting; Research; Research Design; Research Ethics; Research Personnel; Role; Safety; Score; Semisodium Valproate; Severities; Standards of Weights and Measures; Statistically Significant; Substance Use Disorder; Substance abuse problem; Suicide; Symptoms; Training; Violence; Week; day; design; drinking; placebo controlled study; programs; randomized placebo controlled trial; service utilization; topiramate; treatment program; trial comparing

DESCRIPTION (provided by applicant): This K-23 award application is designed to enhance the candidate's research expertise in the area of alcohol dependence (AD) co-occurring with bipolar disorder (BD). As many as 60% of bipolar patients have lifetime alcohol and substance use disorders. These patients have a more severe course of illness, marked by greater service utilization, more suicidality, more severe mood symptoms, increased violence, poor treatment adherence, and lower functioning. Remarkably, only one randomized controlled trial published to date has studied the treatment of AD when it co-occurs with BD in adults. Topiramate decreases drinking in a non-psychiatrically ill, alcohol-dependent population, but the efficacy of topiramate for AD in patients with BD is unknown. The goal of the proposed project is to study the efficacy and safety of adjunctive topiramate treatment of AD in patients with bipolar I or II disorder in a randomized, placebo-controlled trial. The primary hypothesis is that subjects randomized to topiramate will have a lower proportion of heavy drinking days at the completion of the trial compared to the placebo group. The training plan includes mentoring and consultation from experts in alcohol and substance abuse and BD, as well as biostatistics pertaining to clinical trial design and analysis. Dr. Roger Weiss, Clinical Director of the Alcohol and Drug Abuse Treatment Program at McLean Hospital, is the mentor. Dr. Joseph Calabrese, the Co-Director of a Health Research Services Administration's Center of Excellence for the Care and Study of Patients with Bipolar Disorder Comorbid with Drug and Alcohol Abuse, and Dr. Andrew Nierenberg, the PI of the Bipolar Trials Network of the NIMH, are co-mentors. Dr. Bankole Johnson, the PI of trials of topiramate for AD, and Dr. Ihsan Salloum, the PI of a trial of sodium divalproex for AD and BD, are consultants. The didactic component of the application will specifically include coursework in research design, advanced biostatistics, and research ethics. In addition to providing important data for the treatment of AD with BD, this project award will facilitate the candidate's transition to an independent investigator able to conduct clinical trials in AD and co-occuring mood disorders. Bipolar Clinic and Research Program, Massachusetts General Hospital; Boston, MA

描述（由申请人提供）：此K-23奖申请旨在提高候选人在酒精依赖（AD）与双相情感障碍（BD）共存领域的研究专业知识。多达60%的双相情感障碍患者终生患有酒精和物质使用障碍。这些患者有更严重的病程，其特征是更大的服务利用率，更多的自杀倾向，更严重的情绪症状，暴力增加，治疗依从性差，功能低下。值得注意的是，迄今为止，只有一项随机对照试验研究了成人AD与BD同时发生时的治疗。托吡酯可减少非精神病性酒精依赖人群的饮酒量，但托吡酯治疗BD患者AD的疗效尚不清楚。本研究的目的是在一项随机、安慰剂对照试验中研究托吡酯连续治疗双相I型或II型AD患者的疗效和安全性。主要假设是随机分配至托吡酯组的受试者在试验结束时重度饮酒天数比例低于安慰剂组。 培训计划包括酒精和药物滥用和BD专家的指导和咨询，以及与临床试验设计和分析有关的生物统计学。姆克林医院酒精和药物滥用治疗项目的临床主任罗杰韦斯博士是导师。Joseph Calabrese博士是健康研究服务管理局双相情感障碍合并药物和酒精滥用患者护理和研究卓越中心的联合主任，Andrew Nierenberg博士是NIMH双相情感障碍试验网络的PI。托吡酯治疗AD试验的PI Bankole约翰逊博士和双丙戊酸钠治疗AD和BD试验的PI Ihsan Salloum博士是顾问。应用程序的教学部分将具体包括研究设计，先进的生物统计学和研究伦理学的课程。除了为BD治疗AD提供重要数据外，该项目奖将促进候选人过渡到能够在AD和并发情绪障碍中进行临床试验的独立研究者。双极临床和研究项目，马萨诸塞州总医院;马萨诸塞州波士顿