Improving Outcomes in Pharmacotherapy of Social Phobia

改善社交恐惧症药物治疗的效果

• 批准号: 7284786
• 负责人: MARK H POLLACK
• 金额: $ 32.88万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-28 至 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7284786
• 关键词: Address; Affect; Age; Antidepressive Agents; Anxiety; Anxiety Disorders; Area; Benzodiazepines; California; Catecholamines; Characteristics; Classification; Clinic; Clinical; Clonazepam; Communities; Comorbidity; Condition; Data; Distress; Double-Blind Method; Ensure; Evaluation; Face; Functional disorder; General Hospitals; Genes; Genetic Polymorphism; High Prevalence; Individual; Intervention; Knowledge; Label; Massachusetts; Metabolism; Modeling; Morbidity - disease rate; Numbers; Outcome; Patient Care; Patients; Pharmaceutical Preparations; Pharmacotherapy; Phase; Placebos; Population; Positioning Attribute; Primary Health Care; Public Health; Randomized; Relative (related person); Research; Research Personnel; SWI1; Safety; Selective Serotonin Reuptake Inhibitor; Serotonin; Sertraline; Site; Social Phobia; Study Subject; Universities; Week; base; day; experience; improved; programs; psychopharmacologic; psychosocial; randomized placebo controlled trial; response; social; stress related disorder; treatment duration; venlafaxine; week trial

DESCRIPTION (provided by applicant): Social anxiety disorder (also referred to as social phobia) is among the most common psychiatric conditions in the community, and is associated with significant distress and dysfunction in affected individuals. This combination of high prevalence (conservatively 4-5%) and substantial attendant morbidity in generalized social anxiety disorder (GSAD) positions it as a serious public health problem. Although currently available treatments for GSAD are efficacious, most patients remain residually symptomatic after initial psychosocial or psychopharmacological intervention. Clinicians regularly face the question of what to do next for these patients, but there are no empirically derived data available to guide clinical practice regarding the relative benefits of "next step" strategies to improve outcome. The absence of such data is a substantial barrier to advancing knowledge and patient care in this area. Given the extensive use of medication treatment in psychiatric and primary care settings and the relative dearth of availability of empirically based psychosocial therapies outside of rarified research settings, we are proposing a 5-year study to systematically assess the relative efficacy of alternate pharmacologic treatment strategies in patients with GSAD remaining symptomatic despite initial SSRI pharmacotherapy. In addition, we will examine predictors of response (e.g., age at onset, duration of illness, comorbidity) to initial SSRI therapy and predictors of differential response to the strategies under study. We will also examine whether polymorphisms in well-studied genes that influence serotonin and/or catecholamine metabolism influence response to treatment in GSAD. The study comprises a double-blind, placebo controlled, randomized trial to compare the relative benefits of the addition of a benzodiazepine (clonazepam), or a switch to an alternative antidepressant (venlafaxine extended-release), for patients with GSAD who remain symptomatic after a 10-week trial of sertraline alone. One hundred sixty-three patients will be entered at each of the three sites (total N = 490): the Center for Anxiety and Traumatic Stress Related Disorders at the Massachusetts General Hospital, the Anxiety Disorders Program at the University of California San Diego, and the Anxiety Disorders Clinic at McMaster University. The CMSD mechanism is being employed to take advantage of each of the sites' previous experience with the systematic evaluation and treatment of individuals with GSAD and to ensure timely recruitment of an adequate number of subjects. This study will provide systematic, prospectively derived data in an understudied area - that of improving outcomes in patients with anxiety disorders. It thus directly addresses a critical public health issue that adversely affects a substantial proportion of the population.

描述（由申请人提供）：社交焦虑症（也称为社交恐惧症）是社区中最常见的精神疾病之一，与受影响个体的严重痛苦和功能障碍有关。广泛性社交焦虑障碍 (GSAD) 的高患病率（保守估计为 4-5%）和大量伴随发病率相结合，使其成为一个严重的公共卫生问题。尽管目前 GSAD 的治疗方法是有效的，但大多数患者在最初的社会心理或精神药理学干预后仍然残留症状。临床医生经常面临这样的问题：下一步该对这些患者做什么，但没有可用的经验数据来指导临床实践，了解“下一步”策略改善结果的相对益处。缺乏此类数据是推进该领域知识和患者护理的重大障碍。 鉴于药物治疗在精神科和初级保健机构中的广泛使用，以及在稀有研究机构之外相对缺乏基于经验的心理社会疗法，我们提议进行一项为期 5 年的研究，系统评估替代药物治疗策略对 GSAD 患者的相对疗效，尽管最初接受了 SSRI 药物治疗，但仍有症状。此外，我们将检查对初始 SSRI 治疗的反应预测因素（例如发病年龄、病程、合并症）以及对所研究策略的差异反应的预测因素。我们还将检查影响血清素和/或儿茶酚胺代谢的经过充分研究的基因的多态性是否会影响 GSAD 的治疗反应。该研究包括一项双盲、安慰剂对照、随机试验，旨在比较添加苯二氮卓类药物（氯硝西泮）或改用替代抗抑郁药（文拉法辛缓释剂）对于 GSAD 患者的相对益处，这些患者在单独使用舍曲林试验 10 周后仍然有症状。三个地点各招募 163 名患者（总数 N = 490）：马萨诸塞州总医院焦虑和创伤性应激相关疾病中心 医院、加州大学圣地亚哥分校的焦虑症项目和麦克马斯特大学的焦虑症诊所。 CMSD 机制的运用是为了利用每个中心以前对 GSAD 个体进行系统评估和治疗的经验，并确保及时招募足够数量的受试者。 这项研究将在一个尚未研究的领域提供系统的、前瞻性的数据——改善焦虑症患者的治疗结果。因此，它直接解决了对相当一部分人口产生不利影响的关键公共卫生问题。