Comparative Effectiveness Study for Bipolar Disorder

双相情感障碍的比较有效性研究

• 批准号: 8008954
• 负责人: ANDREW A NIERENBERG
• 金额: $ 978.49万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2013-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8008954
• 关键词: Comparative; Effectiveness; Study; Bipolar; Disorder

DESCRIPTION (provided by applicant): Bipolar is a severe and lifelong illness affecting 4.5% of the population - about 14 million people in the U.S. It is one of the top 10 most disabling medical conditions worldwide according to the World Health Organization. Traditionally, the mood stabilizer lithium (Li) has been used extensively for the treatment of acute mood episodes (mania and depression) and for maintenance prevention of relapse. However, in recent years, second generation antipsychotics (SGAs; e.g., quetiapine [QTP], olanzapine, and aripiprazole) have rapidly supplanted older medications for both acute and maintenance treatment. In fact, QTP has become the most commonly prescribed medication for bipolar disorder. This is true in spite of the observation that treatment with SGAs is associated with significant metabolic and, potentially, cardiovascular risk, owing to their adverse effects of weight gain, dyslipidemias, and type II diabetes. To date, however, there have been no large-scale, randomized comparative effectiveness studies comparing SGA's against older mood stabilizers for the acute or maintenance treatment of bipolar disorder in real-world settings. The comparative risks and benefits of SGAs versus older medications such as Li for bipolar disorder assessed in real-world settings and patients represent public health questions of major significance. Therefore, the primary aim of this study is to evaluate comparative benefits and harms for QTP versus Li in bipolar outpatients over a period of 6 months. QTP and Li will be combined with other medications for bipolar disorder (adjunct personalized treatment [APT], excluding QTP for lithium treated patients and lithium for QTP patients) in parallel with typical clinical practice. A co-primary aim will be to assess the frequency of necessary clinical adjustments (NCAs) of medications for the groups randomized to QTP+APT versus Li+APT. Secondary aims will be to compare the effect of QTP+APT versus Li+APT on: 1. The future risk of cardiovascular disease as measured by change in the Framingham General Cardiovascular Risk Score over the course of 6 months; and 2. Functional status. Exploratory aims will be to assess moderators of response to QTP+APT or Li+APT, to include underserved racial and ethnic minority status, comorbid psychiatric and medical disorders, younger (age >18 and <25 years) and older (> 55 years) age. Genetic material will also be collected and sent to the NIMH tissue bank on well-characterized participants with well-defined longitudinal response to QTP+APT or Li+APT for future pharmacogenomic studies. This study has a very high potential to have a major public health impact and to change the treatment of millions of Americans with bipolar disorder. PUBLIC HEALTH RELEVANCE: This study will compare two treatments over 6 months for participants with bipolar disorder who present with at least mild symptoms and who require a change in treatment. The two treatments will be the second generation antipsychotic mood stabilizer quetiapine and the classic mood stabilizer lithium. In addition to quetiapine or lithium, participants can be treated with other medications as needed.

描述(申请人提供)：双相情感障碍是一种严重的终生疾病，影响着4.5%的美国人口--美国约有1400万人。根据世界卫生组织的数据，它是全球十大致残率最高的疾病之一。传统上，情绪稳定剂锂(Li)被广泛用于治疗急性情绪发作(躁狂和抑郁)和维持预防复发。然而，近年来，第二代抗精神病药物(SGAs；例如奎硫平[QTP]、奥氮平和阿立哌唑)在急性和维持治疗中迅速取代了旧药物。事实上，QTP已经成为治疗双相情感障碍最常用的处方药。这是真的，尽管有观察到，由于体重增加、血脂异常和II型糖尿病的不利影响，使用SGAS治疗与显著的代谢和潜在的心血管风险相关。然而，到目前为止，还没有大规模的随机比较研究将SGA与较老的情绪稳定剂在现实环境中急性或维持治疗双相情感障碍的有效性进行比较。SGAs与治疗双相情感障碍的旧药(如LI)的风险和益处的比较，是在现实世界环境和患者中进行评估的，代表了具有重大意义的公共卫生问题。因此，这项研究的主要目的是评估QTP与LI在双相情感障碍门诊患者6个月期间的比较益处和危害。QTP和LI将与其他治疗双相情感障碍的药物(辅助个性化治疗[APT]，不包括锂治疗患者的QTP和QTP患者的锂治疗)结合在一起，同时进行典型的临床实践。共同的主要目标将是评估QTP+APT和LI+APT随机分组的药物必要临床调整(NCA)的频率。次要目标将是比较QTP+APT和LI+APT在以下方面的效果：1.通过6个月期间弗雷明翰心血管风险评分的变化来衡量心血管疾病的未来风险；以及2.功能状态。探索性目标将是评估对QTP+APT或LI+APT的反应的调节因素，包括服务不足的种族和少数民族地位、并存的精神和医学障碍、较年轻(18岁和25岁)和较大(55岁)。遗传物质也将被收集并发送到NIMH组织库，研究对象是对QTP+APT或Li+APT有明确纵向反应的特征良好的参与者，用于未来的药物基因组学研究。这项研究极有可能对公众健康产生重大影响，并改变数百万美国双相情感障碍患者的治疗方法。 与公共卫生相关：这项研究将在6个月内比较双相情感障碍患者的两种治疗方法，这些患者至少有轻微的症状，需要改变治疗。这两种疗法将是第二代抗精神病情绪稳定剂奎硫平和经典情绪稳定剂锂。除了奎硫平或锂，参与者还可以根据需要接受其他药物治疗。

项目成果

Poor quality of life and functioning in bipolar disorder.

• DOI: 10.1186/s40345-017-0078-4
• 发表时间: 2017-12
• 期刊: International journal of bipolar disorders
• 影响因子: 4
• 作者: Sylvia LG;Montana RE;Deckersbach T;Thase ME;Tohen M;Reilly-Harrington N;McInnis MG;Kocsis JH;Bowden C;Calabrese J;Gao K;Ketter T;Shelton RC;McElroy SL;Friedman ES;Rabideau DJ;Nierenberg AA
• 通讯作者: Nierenberg AA

The impact of binge eating behavior on lithium- and quetiapine-associated changes in body weight, body mass index, and waist circumference during 6 months of treatment: Findings from the bipolar CHOICE study.

治疗 6 个月期间暴食行为对锂和喹硫平相关的体重、体重指数和腰围变化的影响：双相 CHOICE 研究的结果。

• DOI: 10.1016/j.jad.2018.09.025
• 发表时间: 2020
• 期刊: Journal of affective disorders
• 影响因子: 6.6
• 作者: Yaramala,SatyanarayanaR;McElroy,SusanL;Geske,Jennifer;Winham,Stacey;Gao,Keming;Reilly-Harrington,NoreenA;Ketter,TerenceA;Deckersbach,Thilo;Kinrys,Gustavo;Kamali,Masoud;Sylvia,LouisaG;McInnis,MelvinG;Friedman,EdwardS;Thase,
• 通讯作者: Thase,

Childhood trauma and treatment outcomes during mood-stabilising treatment with lithium or quetiapine among outpatients with bipolar disorder.

• DOI: 10.1111/acps.13420
• 发表时间: 2022-06
• 期刊: ACTA PSYCHIATRICA SCANDINAVICA
• 影响因子: 6.7
• 作者: Wrobel, Anna L.;Koehler-Forsberg, Ole;Sylvia, Louisa G.;Russell, Samantha E.;Dean, Olivia M.;Cotton, Sue M.;Thase, Michael;Calabrese, Joseph R.;Deckersbach, Thilo;Tohen, Mauricio;Bowden, Charles L.;McInnis, Melvin G.;Kocsis, James H.;Friedman, Edward S.;Ketter, Terence A.;Shelton, Richard C.;Ostacher, Michael J.;Iosifescu, Dan, V;Berk, Michael;Turner, Alyna;Nierenberg, Andrew A.
• 通讯作者: Nierenberg, Andrew A.

Sleep disturbance may impact treatment outcome in bipolar disorder: A preliminary investigation in the context of a large comparative effectiveness trial.

• DOI: 10.1016/j.jad.2017.08.056
• 发表时间: 2018
• 期刊: Journal of affective disorders
• 影响因子: 6.6
• 作者: L. Sylvia;Weilynn C. Chang;M. Kamali;M. Tohen;G. Kinrys;T. Deckersbach;J. Calabrese;M. Thase;N. Reilly-Harrington;W. Bobo;J. Kocsis;M. McInnis;C. Bowden;T. Ketter;E. Friedman;R. Shelton;S. McElroy;K. Gao;D. Rabideau;A. Nierenberg

Psychotherapy use in bipolar disorder: Association with functioning and illness severity.

心理治疗在双相情感障碍中的应用：与功能和疾病严重程度的关联。

• DOI: 10.1177/0004867415569803
• 发表时间: 2015
• 期刊: The Australian and New Zealand journal of psychiatry
• 作者: Sylvia,LouisaG;Thase,MichaelE;Reilly-Harrington,NoreenA;Salcedo,Stephanie;Brody,Benjamin;Kinrys,Gustavo;Kemp,David;Shelton,RichardC;McElroy,SusanL;Kocsis,JamesH;Bobo,WilliamV;Kamali,Masoud;McInnis,Melvin;Friedman,Edward