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


OBJECTIVE
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.


METHODS
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 response or in the adverse side effects of treatment with Aripiprazole.
Research Network CIBER, Spain. Isabel.Montero@uv.es
Isabel
I
Montero
Marta
M
Talavera
Isabel
I
Ruiz
D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000068180:Aripiprazole; D005260:Female; D006801:Humans; D008297:Male; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012559:Schizophrenia / Q000188:drug therapy* / Q000517:prevention & control; D012565:Schizophrenic Psychology; D017678:Sex Distribution; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole