title: Open-label prospective trial of risperidone in combination with lithium or divalproex sodium in pediatric mania.
abstract: OBJECTIVE
  This prospective 6-month open trial examined the safety and efficacy of two combination therapies for manic or mixed episodes of pediatric bipolar disorder: (1) divalproex sodium plus risperidone (DVPX+Risp), or (2) lithium plus risperidone (Li+Risp).
  
  
  METHODS
  Thirty-seven (37) subjects aged 5 and 18 (age=12.1+/-3.5 years) with DSM IV current mixed or manic episode and Young Mania Rating Scale (YMRS) score >20 were sequentially assigned to either DVPX+Risp or Li+Risp in a 6-month, prospective open-label trial. Outcome measures included the YMRS, Clinical Global Impression Scale for Bipolar Disorder (CGI-BP), Child Depression Rating Scale-Revised (CDRS-R) as well as measures of safety and tolerability.
  
  
  RESULTS
  Effect sizes (Cohen's d) based on change of YMRS scores from baseline were 4.36 for DVPX+Risp and 2.82 for Li+Risp. Response rates (>or=50% change from baseline YMRS score at the end of study) were 80% for DVPX+Risp and 82.4% for Li+Risp. Both combination treatments were well tolerated. Significant improvements (p<0.001) from baseline were seen for mean scores on all efficacy measures, i.e., YMRS, CGI-BP, and CDRS-R. There were no significant group differences in safety or tolerability, and no serious adverse events during the 6-month trial.
  
  
  CONCLUSIONS
  Both DVPX+Risp and Li+Risp show strong effects coupled with safety and tolerability in treating children and adolescents with manic or mixed episodes associated with type I bipolar disorder.
authors.affiliation: Pediatric Bipolar Research Program, Department of Psychiatry, University of Illinois at Chicago (UIC), Chicago, IL 60612, USA. mpavuluri@psych.uic.edu
authors.forename: Mani N
authors.initials: MN
authors.lastname: Pavuluri
authors.forename: David B
authors.initials: DB
authors.lastname: Henry
authors.forename: Julie A
authors.initials: JA
authors.lastname: Carbray
authors.forename: Gwendolyn
authors.initials: G
authors.lastname: Sampson
authors.forename: Michael W
authors.initials: MW
authors.lastname: Naylor
authors.forename: Philip G
authors.initials: PG
authors.lastname: Janicak
mesh_terms: D000293:Adolescent; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000523:psychology; D002648:Child; D002675:Child, Preschool; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D016651:Lithium Carbonate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D018967:Risperidone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014635:Valproic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D014150:Antipsychotic Agents; D016651:Lithium Carbonate; D014635:Valproic Acid; D018967:Risperidone