Operations and Clinical Assessment Core

CIDAR运营和临床评估核心(OCAC)负责管理职能， 数据管理和生物统计，以及CIDAR临床算法的组织和维护 (CCA)为首发精神分裂症患者提供标准化治疗和评估 抗精神病药物治疗的第一年。CIDAR CCA将从大量(n=242)第一个 发作性精神分裂症患者参加了一项资助的为期12周的随机、双盲比较 利培酮或阿立哌唑为首发治疗(第二季01-60004：预防首发发病 精神分裂症；PI：Delbert Robinson)。CIDAR OCAC将提供支持，以在 使用这两种药物(或氯氮平治疗难治性药物)的标准化开放标签治疗算法 在总共52周的研究期间的剩余时间内)。CCA旨在最大限度地减少 在道德实践的范围内，患者接受的治疗的异质性。 OCAC还为数据管理功能提供支持，包括：表单开发；数据库 编程；生成研究报告和数据库查询；维护数据库安全和完整性； 进行数据库备份；数据质量保证和审计。此外，OCAC提供了统计数据 支持包括：提出假设和目标；主要和次要终点和多个 检验；统计方法；治疗意向；缺失数据；以及样本量和力量。 OCAC将确保各个CIDAR项目方法的一致性，每个项目都是 旨在测试有关治疗反应预测的假设。CIDAR评估范围 领域范围(阳性和阴性症状、体重增加和代谢变化、运动方面 在双盲试验期间，将每周(前4周)进行一次，然后每两周进行一次。每月 对52周CCA持续时间的评估将由一个由蒙面评分员组成的中央团队进行 所有这些都由OCAC以高标准的可靠性进行培训和维护。每个患者的功能结果 将为每个患者在离开CCA时进行评估。CIDAR项目将被提供一个关键的“菜单” 依赖测量，将先验定义为为期12周的随机试验的关键终点，以及完整的52- 每周CCA。一般说来，将使用严格的、临床上有意义的标准来定义应答，就像我们之前的第一个标准一样 插曲研究。此外，每个CIDAR项目都有能力检测与临床相关的 认知、神经影像和遗传变异对治疗反应的关键措施。

The CIDAR Operations and Clinical Assessment Core (OCAC) is responsible for administrative functions, data management and biostatistics, and the organization and maintenance of the CIDAR Clinical Algorithm (CCA) that provides standardized treatment and assessment of first episode schizophrenia patients during the first year of antipsychotic treatment. The CIDAR CCA will draw from a large number (n=242) of first episode schizophrenia patients enrolled in a funded 12-week randomized, double-blind comparison of risperidone or aripiprazole as first treatment, (2R01 MH 60004: Preventing morbidity in first episode schizophrenia; PI: Delbert Robinson). The CIDAR OCAC will provide support to maintain these subjects in a standardized, open-label treatment algorithm with these two agents (or clozapine in treatment refractory patients) for the remainder of a total 52-week study period. The CCA was designed to minimize the heterogeneity of treatments that patients receive, within the limits of ethical practice. The OCAC also provides support for data management functions, including: forms development; database programming; generating study reports and database queries; maintaining database security and integrity; conducting database backups; data quality assurance and auditing. Further, the OCAC provides statistical support including: formulation of hypotheses and aims; primary and secondary endpoints and multiple testing; statistical methods; intention-to-treat; missing data; and sample size and power. The OCAC will ensure consistency of methodology for the individual CIDAR projects, each of which is designed to test hypotheses concerning prediction of treatment response. CIDAR assessments across a range of domains (positive and negative symptoms, weight gain and metabolic changes, motoric side effects) will be conducted weekly (first 4 weeks), then biweekly, during the double-blind trial. Monthly assessments for the duration of the 52-week CCA will be conducted by a centralized team of masked raters all trained and maintained at high standards of reliability by the OCAC. Functional outcome for each patient will be assessed for each patient upon exiting the CCA. CIDAR projects will be provided a "menu" of key dependent measures, defined a priori as critical endpoints for the 12-week randomized trial and the full 52- week CCA. In general, response will be defined using strict, clinically meaningful criteria as in our prior first episode studies. Moreover, each of the CIDAR projects is powered to detect clinically relevant effects of cognitive, neuroimaging, and genetic variation on the key treatment response measures.