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 duringthe first year of antipsychotic treatment. The CIDAR CCA will draw from a large number (n=242) of firstepisode schizophrenia patients enrolled in a funded 12-week randomized, double-blind comparison ofrisperidone or aripiprazole as first treatment, (2R01 MH 60004: Preventing morbidity in first episodeschizophrenia; PI: Delbert Robinson). The CIDAR OCAC will provide support to maintain these subjects in astandardized, open-label treatment algorithm with these two agents (or clozapine in treatment refractorypatients) for the remainder of a total 52-week study period. The CCA was designed to minimize theheterogeneity of treatments that patients receive, within the limits of ethical practice.The OCAC also provides support for data management functions, including: forms development; databaseprogramming; generating study reports and database queries; maintaining database security and integrity;conducting database backups; data quality assurance and auditing. Further, the OCAC provides statisticalsupport including: formulation of hypotheses and aims; primary and secondary endpoints and multipletesting; 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 isdesigned to test hypotheses concerning prediction of treatment response. CIDAR assessments across arange of domains (positive and negative symptoms, weight gain and metabolic changes, motoric sideeffects) will be conducted weekly (first 4 weeks), then biweekly, during the double-blind trial. Monthlyassessments for the duration of the 52-week CCA will be conducted by a centralized team of masked ratersall trained and maintained at high standards of reliability by the OCAC. Functional outcome for each patientwill be assessed for each patient upon exiting the CCA. CIDAR projects will be provided a 'menu' of keydependent 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 firstepisode studies. Moreover, each of the CIDAR projects is powered to detect clinically relevant effects ofcognitive, neuroimaging, and genetic variation on the key treatment response measures.
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