Clinical trials with a new atypical antipsychotic (Aripiprazole): gender specific information analysis.

ABSTRACT Introduction: In 1993, the Food and Drug Administration (FDA) published a guideline for the study and evaluation of gender-related differences in clinical trials. However, the extent of the implementation of these recommendations has not been systematically reviewed. Objectives: To determine the proportion of women in clinical trials of Aripiprazole, a new atypical antipsychotic, and to analyze the resulting information on a gender-specific basis. Method: A systematic review was conducted in Medline to identify randomized trials that compared this new antipsychotic drug with placebo or with typical or atypical antipsychotics in patients diagnosed with schizophrenia. The FDA Guideline was followed for the study and evaluation of gender-specific results of clinical trials. Results: Despite the inclusion of female participants in the samples studied, the failure to conduct analyses stratified by sex prevented us from ascertaining the possible differences between men and women in the therapeutic resp...