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J Clin Psychiatry. 2003 Nov;64(11):1362-9.

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

Author information

1
University Hospitals of Cleveland/Case Western Reserve University, Cleveland, Ohio 44106, USA. robert.findling@uhhs.com

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.

PMID:
14658952
[Indexed for MEDLINE]

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