Assessment of adverse effects in clinical studies of antipsychotic medication: survey of methods used

Background Clinical studies of antipsychotic medication are a primary source of data on the nature of, and relative liability for, adverse effects, relevant to prescribing decisions in clinical practice. Aims To identify how safety and tolerability data were collected and reported in recent clinical studies of antipsychotics. Method A survey was conducted of all 167 eligible studies published between 2002 and 2007 on the Cochrane Schizophrenia Group register. Results Extrapyramidal side-effects (EPS) and weight gain were most frequently assessed. A minority of reports addressed metabolic abnormalities, aversive subjective experiences and sexual dysfunction. Published rating scales were frequently used to evaluate EPS, but systematic methods were rarely applied to other treatment-emergent problems. The definition of individual adverse effects and the manner of reporting were inconsistent. Conclusions The way in which safety anti tolerability data are collected and reported in clinical studies does not allow for fair and meaningful comparison of the relative risk profiles of individual antipsychotic drugs.