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Open Access Highly Accessed Research article

The effect of antipsychotic medication on sexual function and serum prolactin levels in community-treated schizophrenic patients: results from the Schizophrenia Trial of Aripiprazole (STAR) study (NCT00237913)

Linda Hanssens1*, Gilbert L'Italien2, Jean-Yves Loze3, Ronald N Marcus2, Miranda Pans1 and Wendy Kerselaers1

Author Affiliations

1 Bristol-Myers Squibb Company, Parc de l'Alliance, Avenue de Finlande, 8, B-1420 Braine-l'Alleud, Belgium

2 Bristol-Myers Squibb Company, 5 Research Parkway, Wallingford, CT 06492, USA

3 Otsuka Pharmaceutical France SAS, "Les Colonnades" -4, rue Henri Sainte Claire Deville, 92500 Rueil-Malmaison, France

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BMC Psychiatry 2008, 8:95  doi:10.1186/1471-244X-8-95

Published: 22 December 2008

Abstract

Background

The aim of this paper is to evaluate the effect of antipsychotics for the treatment of schizophrenia in a community based study on sexual function and prolactin levels comparing the use of aripiprazole and standard of care (SOC), which was a limited choice of three widely used and available antipsychotics (olanzapine, quetiapine or risperidone) (The Schizophrenia Trial of Aripiprazole [STAR] study [NCT00237913]).

Method

This open-label, 26-week, multi-centre, randomised study compared aripiprazole to SOC (olanzapine, quetiapine or risperidone) in patients with schizophrenia (DSM-IV-TR criteria). The primary effectiveness variable was the mean total score of the Investigator Assessment Questionnaire (IAQ) at Week 26. The outcome research variables included the Arizona Sexual Experience scale (ASEX). This along with the data collected on serum prolactin levels at week 4, 8, 12, 18 and 26 will be the focus of this paper.

Results

A total of 555 patients were randomised to receive aripiprazole (n = 284) or SOC (n = 271). Both treatment groups experienced improvements in sexual function from baseline ASEX assessments. However at 8 weeks the aripiprazole treatment group reported significantly greater improvement compared with the SOC group (p = 0.007; OC). Although baseline mean serum prolactin levels were similar in the two treatment groups (43.4 mg/dL in the aripiprazole group and 42.3 mg/dL in the SOC group, p = NS) at Week 26 OC, mean decreases in serum prolactin were 34.2 mg/dL in the aripiprazole group, compared with 13.3 mg/dL in the SOC group (p < 0.001).

Conclusion

The study findings suggest that aripiprazole has the potential to reduce sexual dysfunction, which in turn might improve patient compliance.