Using defined inclusion criteria to establish baseline cognitive deficits in CIAS clinical trials

Cognitive deficits are a core feature of schizophrenia but not all patients function below the normal range expected in the absence of illness.^1,2  Although 98% of patients with schizophrenia may qualify as cognitively impaired compared to antecedent expectations such as premorbid intelligence³, some patients will still not meet neuropsychological criteria for clinically relevant impairment. For a positive signal to be detected in a clinical trial, an improvement of large effect size must be seen which may be more likely when the study population consists of patients exhibiting clinically relevant cognitive impairments. The aim of this research was to establish the extent to which subjects are prescreened for cognitive deficits in schizophrenia clinical trials using cognition as an endpoint. 

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Tags : schizophrenia | schizophrenia research | cias | clinical trials