26316
document
Effects of short- and long-term risperidone treatment on prolactin levels in children with autism . BACKGROUND The effects of short- and long-term risperidone treatment on serum prolactin were assessed in children and adolescents with autism . METHODS Patients with autism ( N = 101 , 5-17 years of age ) were randomized to an 8-week trial of risperidone or placebo and 63 then took part in a 4-month open-label follow-up phase . Serum samples were obtained at Baseline and Week-8 ( N = 78 ) , and at 6-month ( N = 43 ) and 22-month ( N = 30 ) follow-up . Serum prolactin was determined by immunoradiometric assay ; dopamine type-2 receptor ( DRD2 ) polymorphisms were genotyped . RESULTS Baseline prolactin levels were similar in the risperidone ( N = 42 ) and placebo ( N = 36 ) groups ( 9.3 +/- 7.5 and 9.3 +/- 7.6 ng/ml , respectively ) . After 8 weeks of risperidone , prolactin increased to 39.0 +/- 19.2 ng/ml , compared with 10.1 +/- 8.8 ng/ml for placebo ( p < .0001 ) . Prolactin levels were also significantly increased at 6 months ( 32.4 +/- 17.8 ng/ml ; N = 43 , p < .0001 ) and at 22 months ( N = 30 , 25.3 +/- 15.6 ng/ml , p < .0001 ) . Prolactin levels were not associated with adverse effects and DRD2 alleles ( Taq1A , -141C Ins/Del , C957T ) did not significantly influence baseline levels or risperidone-induced increases in prolactin . CONCLUSIONS Risperidone treatment was associated with two- to four-fold mean increases in serum prolactin in children with autism . Although risperidone-induced increases tended to diminish with time , further research on the consequences of long-term prolactin elevations in children and adolescents is needed .
26317
Intervention_Pharmacological
risperidone
26318
Intervention_Pharmacological
risperidone
26319
Intervention_Pharmacological
risperidone
26320
Intervention_Control
placebo
26321
Intervention_Pharmacological
risperidone
26322
Intervention_Control
placebo
26323
Intervention_Pharmacological
risperidone
26324
Intervention_Pharmacological
Risperidone
26325
Outcome_Physical
prolactin levels
26326
Outcome_Other
dopamine type-2 receptor ( DRD2 ) polymorphisms were genotyped .
26327
Outcome_Physical
Baseline prolactin levels
26328
Outcome_Physical
prolactin
26329
Outcome_Physical
Prolactin levels
26330
Outcome_Physical
Prolactin levels