Literature DB >> 14658952

Prolactin levels during long-term risperidone treatment in children and adolescents.

Robert L Findling1, Vivek Kusumakar, Denis Daneman, Thomas Moshang, Goedele De Smedt, Carin Binder.   

Abstract

BACKGROUND: This analysis was designed to investigate prolactin levels in children and adolescents on long-term risperidone treatment and explore any relationship with side effects hypothetically attributable to prolactin (SHAP).
METHOD: Data from 5 clinical trials (total N = 700) were pooled for this post hoc analysis. Children and adolescents aged 5 to 15 years with subaverage intelligence quotients and conduct or other disruptive behavior disorders received risperidone treatment (0.02-0.06 mg/kg/day) for up to 55 weeks. Outcome measures analyzed included serum prolactin levels, reported adverse events, and the conduct problem subscore of the Nisonger Child Behavior Rating Form.
RESULTS: Mean prolactin levels rose from 7.8 ng/mL at baseline to a peak of 29.4 ng/mL at weeks 4 to 7 of active treatment, then progressively decreased to 16.1 ng/mL at weeks 40 to 48 (N = 358) and 13.0 ng/mL at weeks 52 to 55 (N = 42). There was no relationship between pro-lactin levels and age. Females returned to a mean value within the normal range (</= 30 ng/mL) by weeks 8 to 12, and males were close to normal values (</= 18 ng/mL) by weeks 16 to 24. At least 1 SHAP was reported by 13 (2.2%) of 592 children. There was no direct correlation between prolactin elevation and SHAP.
CONCLUSION: With long-term risperidone treatment in children and adolescents, serum prolactin levels tended to rise and peak within the first 1 to 2 months and then steadily decline to values within or very close to the normal range by 3 to 5 months.

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Year:  2003        PMID: 14658952     DOI: 10.4088/jcp.v64n1113

Source DB:  PubMed          Journal:  J Clin Psychiatry        ISSN: 0160-6689            Impact factor:   4.384


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