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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).
BMC Psychiatry. 2008 Dec 22; 8:95.BP

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.

Authors+Show Affiliations

Bristol-Myers Squibb Company, Parc de l'Alliance, Avenue de Finlande, 8, B-1420 Braine-l'Alleud, Belgium. linda.hanssens@bms.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19102734

Citation

Hanssens, Linda, et al. "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)." BMC Psychiatry, vol. 8, 2008, p. 95.
Hanssens L, L'Italien G, Loze JY, et al. 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). BMC Psychiatry. 2008;8:95.
Hanssens, L., L'Italien, G., Loze, J. Y., Marcus, R. N., Pans, M., & Kerselaers, W. (2008). 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). BMC Psychiatry, 8, 95. https://doi.org/10.1186/1471-244X-8-95
Hanssens L, et al. 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). BMC Psychiatry. 2008 Dec 22;8:95. PubMed PMID: 19102734.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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). AU - Hanssens,Linda, AU - L'Italien,Gilbert, AU - Loze,Jean-Yves, AU - Marcus,Ronald N, AU - Pans,Miranda, AU - Kerselaers,Wendy, Y1 - 2008/12/22/ PY - 2007/11/06/received PY - 2008/12/22/accepted PY - 2008/12/24/entrez PY - 2008/12/24/pubmed PY - 2009/3/6/medline SP - 95 EP - 95 JF - BMC psychiatry JO - BMC Psychiatry VL - 8 N2 - 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. SN - 1471-244X UR - https://www.unboundmedicine.com/medline/citation/19102734/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__ L2 - https://bmcpsychiatry.biomedcentral.com/articles/10.1186/1471-244X-8-95 DB - PRIME DP - Unbound Medicine ER -