3/4 Collaboration to Advance Negative Symptom Assessment in Schizophrenia

3/4 合作推进精神分裂症阴性症状评估

• 批准号: 8021033
• 负责人: WILLIAM P. HORAN
• 金额: $ 27.75万
• 依托单位: BRENTWOOD BIOMEDICAL RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8021033
• 关键词: Academia; Address; Adverse effects; Agreement; Antipsychotic Agents; Anxiety; Applications Grants; Area; Behavior; California; Caregiver Burden; Caregivers; Characteristics; Charge; Clinical; Clinical Trials; Cognition; Collaborations; Communities; Conduct Clinical Trials; Consensus; Consensus Development Conferences; Data; Data Analyses; Data Collection; Development; Disease; Distress; Drug Industry; Emotional; Ensure; Evaluation; Factor Analysis; Gender; Generations; Government Agencies; Gur; Health; Impairment; Industry; Interviewer; Lead; Los Angeles; Manuals; Maryland; Measurement; Measures; Methods; Modeling; Moods; Motivation; National Institute of Mental Health; Neurocognitive; Occupational; Outcome; Outpatients; Participant; Patient Self-Report; Patients; Pennsylvania; Pharmaceutical Preparations; Pharmacotherapy; Phase; Play; Positioning Attribute; Principal Investigator; Procedures; Process; Property; Psychology; Psychometrics; Recommendation; Recruitment Activity; Research; Research Infrastructure; Research Personnel; Research Priority; Role; Sampling; Schizoaffective Disorders; Schizophrenia; Severities; Sex Characteristics; Site; Social Functioning; Source; Structure; Symptoms; Techniques; Testing; Therapy Clinical Trials; Training; United States Food and Drug Administration; Universities; Validity and Reliability; Woman; Work; base; design; disability; emotional experience; functional outcomes; improved; instrument; meetings; member; men; method development; next generation; novel; programs; quality assurance; response; social; sound; success; symposium; theories; therapy development

DESCRIPTION (provided by applicant): Negative symptoms are distinct clinical features of schizophrenia that are major determinants of the poor community functioning and poor long-term outcome that characterize the disorder. However, they are only minimally responsive to available treatments and are a substantial burden for care-givers. To address this critical unmet treatment need, the NIMH recently sponsored a consensus development conference to identify research priorities to stimulate the development of novel treatments for negative symptoms. The number one recommendation for advancing research and moving towards new treatment development in this area was to develop a "next generation" assessment instrument that solves the conceptual and methodological problems of existing measures. For the instrument to achieve widespread acceptance, the conference participants concluded that it is essential to follow a transparent, rigorous scale development process using large, diverse, and representative samples. As members of the NIMH-MATRICS Negative Symptoms Workgroup, the Principal Investigators have collaborated with experts from academia, the pharmaceutical industry, and government agencies to develop a new instrument, the Negative Symptom Rating Scale (NSRS). The proposed four-site Collaboration to Advance Negative Symptom Assessment in Schizophrenia (CANSAS), including the Universities of Maryland, Pennsylvania, California-Los Angeles, and California-Berkeley, is designed to carry out the recommendations of this NIMH initiative over a three-year period. These four sites represent areas of ongoing research in schizophrenia and negative symptoms, with the necessary infrastructure and unique expertise to carry out the proposed studies. Study 1 will evaluate the psychometric properties of the beta version of the NSRS in 300 schizophrenia outpatients. Results will guide data-driven refinements of the instrument based on state-of-the-art data analytic techniques, including Item Response Theory analyses and item level factor analyses that will allow us to ascertain how well the NSRS items assesses the underlying negative symptom construct and its putative sub-components, the dimensional structure of the measure, and gender invariance. Study 2 will evaluate the psychometric properties, test-retest reliability, and factor structure via confirmatory factor analysis of the revised NSRS in160 patients with schizophrenia. Convergent/discriminant validity with respect to a range of other clinical and neurocognitive features of schizophrenia, as well as measures of social and emotional functioning will also be evaluated. The multi-site structure of the CANSAS will permit an efficient evaluation of the NSRS in large ethnically and clinically diverse samples, enabling us to rapidly disseminate a final version of the scale to researchers conducting clinical trials and other types of negative symptom research. PUBLIC HEALTH RELEVANCE: Negative symptoms are major determinants of poor functional outcome in schizophrenia and available treatments are largely ineffective for these symptoms. The proposed Collaboration to Advance Negative Symptom Assessment in Schizophrenia (CANSAS) will carry out the main recommendation of the recent NIMH Consensus Development Conference to create and validate a new assessment instrument, the Negative Symptom Rating Scale, for use in clinical trials and other types of research. This state-of-the art instrument will play a central role in the NIMH initiative to stimulate the development of new treatments aimed at reducing the disability associated with negative symptoms.

描述(由申请人提供)：阴性症状是精神分裂症的明显临床特征，是社区功能不佳和长期结果不佳的主要决定因素，是这种疾病的特征。然而，它们对可用的治疗只有最低限度的反应，对照顾者来说是一个巨大的负担。为了解决这一关键的未得到满足的治疗需求，NIMH最近主办了一次共识发展会议，以确定研究优先事项，以刺激针对阴性症状的新疗法的开发。在这一领域推进研究和开发新的治疗方法的首要建议是开发解决现有措施的概念和方法问题的“下一代”评估工具。为使该文书获得广泛接受，与会者得出结论，必须遵循透明、严格的规模开发过程，使用大量、多样和有代表性的样本。作为NIMH-Matrics阴性症状工作组的成员，首席调查员与学术界、制药业和政府机构的专家合作开发了一种新的工具，即阴性症状评定量表(NSRS)。拟议的四个地点合作以推进精神分裂症阴性症状评估(CANSAS)，包括马里兰大学、宾夕法尼亚大学、加州-洛杉矶大学和加州-伯克利大学，旨在三年内实施这一NIMH倡议的建议。这四个网站代表了正在进行的精神分裂症和阴性症状研究领域，拥有开展拟议研究所需的基础设施和独特的专业知识。研究1将评估300名门诊精神分裂症患者的NSRS Beta版的心理测量学特性。结果将指导以最先进的数据分析技术为基础的工具的数据驱动的改进，包括项目反应理论分析和项目水平因素分析，这将使我们能够确定NSRS项目评估潜在的负面症状结构及其推定的子成分、测量的维度结构和性别不变性的情况。研究二将通过验证性因素分析对160例精神分裂症患者进行修订后的NSRS的心理测量学特性、重测信度和因子结构的评估。还将评估精神分裂症的其他一系列临床和神经认知特征以及社会和情绪功能指标的会聚/区分效度。CANSAS的多站点结构将允许在大的种族和临床上不同的样本中对NSRS进行有效的评估，使我们能够迅速向进行临床试验和其他类型的阴性症状研究的研究人员传播该量表的最终版本。公共卫生相关性：阴性症状是精神分裂症患者功能预后差的主要决定因素，现有的治疗方法对这些症状基本上无效。拟议的推进精神分裂症阴性症状评估(CANSAS)的合作将执行最近举行的NIMH共识发展会议的主要建议，即创建和验证一种新的评估工具--阴性症状评定量表，用于临床试验和其他类型的研究。这一最先进的仪器将在NIMH倡议中发挥核心作用，以刺激旨在减少与阴性症状相关的残疾的新治疗方法的开发。