title: Tolerability and safety profile of risperidone in a sample of children and adolescents.
abstract: The aim of this prospective observational study was to verify the tolerability and safety profile of risperidone in a sample of antipsychotic-naive children/adolescent patients having a different psychiatric diagnosis. Twenty-two (mean age of 12±3.2) antipsychotic-naive patients who started therapy with risperidone were recruited. The assessment involved anthropometric data (weight, height, BMI, BMI z-score and BMI percentile), cardiovascular parameters (blood pressure and QTc interval) and blood tests (levels of glucose, triglycerides, total cholesterol, glutamic oxaloacetic and pyruvic transaminases, γ-glutamyl transferase, prolactin, free triiodothyronine, free thyroxine, thyroid-stimulating hormone, thyroglobulin, antithyroid peroxidase and antithyroglobulin). After an average follow-up of 6 months of risperidone therapy, a statistically significant increase in weight and body composition was observed. Furthermore, an increase in serum levels of prolactin was observed in 50% of patients. No other significant changes in metabolic and cardiovascular parameters were found. Although an increase in these parameters was detected, it remained in the normal range. This study suggests the use of specific protocols for monitoring children/adolescents treated with second-generation antipsychotics to manage the metabolic long-term complications and progression to more severe disease states.
authors.affiliation: Child Neuropsychiatry Unit, Department of Neuroscience and Sense Organs, Hospital Polyclinic of Bari, University of Aldo Moro Bari, Bari, Italy. l.margari@neurol.uniba.it
authors.forename: Lucia
authors.initials: L
authors.lastname: Margari
authors.forename: Emilia
authors.initials: E
authors.lastname: Matera
authors.forename: Francesco
authors.initials: F
authors.lastname: Craig
authors.forename: Maria G
authors.initials: MG
authors.lastname: Petruzzelli
authors.forename: Vincenzo O
authors.initials: VO
authors.lastname: Palmieri
authors.forename: Adriana
authors.initials: A
authors.lastname: Pastore
authors.forename: Francesco
authors.initials: F
authors.lastname: Margari
mesh_terms: D000293:Adolescent; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D019958:Attention Deficit and Disruptive Behavior Disorders / Q000188:drug therapy*; D001823:Body Composition / Q000187:drug effects; D015992:Body Mass Index; D002648:Child; D002659:Child Development Disorders, Pervasive / Q000188:drug therapy*; D039721:Diagnostic and Statistical Manual of Mental Disorders; D018492:Dopamine Antagonists / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D016903:Drug Monitoring; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011388:Prolactin / Q000097:blood; D018967:Risperidone / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D012559:Schizophrenia / Q000188:drug therapy*; D058830:Serotonin 5-HT2 Receptor Antagonists / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D013981:Tic Disorders / Q000188:drug therapy; D015854:Up-Regulation / Q000187:drug effects; D015430:Weight Gain / Q000187:drug effects
chemical_list: D014150:Antipsychotic Agents; D018492:Dopamine Antagonists; D058830:Serotonin 5-HT2 Receptor Antagonists; D011388:Prolactin; D018967:Risperidone