Clinical Trial, Phase IV
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
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Observational, open-label, prospective multicenter study of sexual function in patients starting treatment with aripiprazole.

INTRODUCTION: Treatment with neuroleptics may be associated with secondary sexual dysfunction. Studies of sexual dysfunction induced by antipsychotic are important to establish the effectiveness of these agents in patients taking chronic treatments. The main objective of this study was to evaluate prospectively whether a 3 month course ofaripiprazole produces changes in the sexual function of patients with schizophrenia.

METHODS: The efficacy analysis was performed in the intention-to-treat population (41 patients) and the per protocol population (36 patients). The safety analysis was based on the total sample (42 patients).

RESULTS: The incidence of sexual dysfunction after 3 months of treatment with aripiprazole was zero both in patients who switched therapy due to lack of efficacy and in those taking aripiprazole as a first antipsychotic. Aripiprazole led to an improvement in the symptoms of psychosis (score on the BPRS) and lower scores on the SALSEX questionnaire.The most remarkable improvement was in delayed eyaculation/orgasm.

CONCLUSION: During the 3 months of treatment, we observed an overall improvement in sexual performance, with a quicker recovery in men than in women, although recovery was similar in both at the end of treatment.

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