Methodological issues in current antipsychotic drug trials. Schizophr Bull

Every year numerous reports on antipsychotic drug trials are being published in neuropsychiatric journals, adding new information to our knowledge in the field. The infor-mation however is often hard for the reader to interpret, sometimes contradictory to comparable available studies and leaves more questions open than it actually answers. Although the overall quality of the studies is rather good, there are manifold options for further improvement in the conception, conduct, and reporting of antipsychotic drug trials. In this survey, we address methodological chal-lenges such as the limited generalizability of outcomes due to patient selection and sample size; the vague or even lack-ing definition of key outcome parameters such as response, remission or relapse, insufficient blinding techniques, the pitfalls of surrogate outcomes and their assessment tools; the varying complex statistical approaches; and the chal-lenge of balancing various ways of reporting outcomes. The authors present practical examples to highlight the current problems and propose a concrete series of sugges-tions on how to further optimize antipsychotic drug trials in the future. Key words: schizophrenia/drug trials/methodology/ antipsychotic