Operations and Clinical Assessment Core

点击翻译按钮获取中文摘要

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.