Computerized Antipsychotic Evaluation System

DESCRIPTION (provided by applicant): Wide-ranging neurocognitive assessment is an integral component of controlled clinical trials of candidate antipsychotic treatments. However, manual administration of large neurocognitive test batteries is inefficient, error prone, relatively costly and does not meet the needs of the pharmaceutical industry as it transitions to computerized clinical trial implementation. The project objective is to develop an advanced, wide spectrum computerized neurocognitive assessment system that provides a single, unified platform for administration of various protocols, and confers the advantages of contemporary information technologies for implementation and management of clinical trials and related research protocols. Advantages of computerization include: increased data quality through standardized administration; automated project reporting and documentation; automated patient tracking and scheduling; automated protocol compliance; reduced examiner requirements and errors; automatic generation and tracking of CRFs; automated electronic database transfer and reduced costs. Computerized administration will, overall, reduce costs to implement clinical trials. The computer platform will be uniquely suited to assessment of impaired subjects due to its interactive dual-display and control architecture which integrates a human examiner. This enables an examiner to score verbal report and overt behavioral performance otherwise not possible with single display systems. To ensure relevance of the assessment instrument battery as well as system functions for application in clinical trials, the proposed hardware-software ensemble will be developed in collaboration with a steering committee of recognized authorities in the field of schizophrenia research, including members of the NIMH sponsored CATIE (Clinical Antipsychotic Trials in Intervention Effectiveness) consortium. In Phase I, the technical utility and concurrent validity of a representative set of test instruments of a prototype system will be determined in a sample of human patients.