Assessment of behavioral and emotional functioning using standardized instruments in children and adolescents with partial-onset seizures treated with adjunctive levetiracetam in a randomized, placebo-controlled trial

Epilepsy Behav. 2010 Jul;18(3):291-8. doi: 10.1016/j.yebeh.2010.04.017. Epub 2010 May 23.

Abstract

A randomized, double-blind, placebo-controlled study (N01103, NCT00105040) evaluated behavioral and emotional effects of adjunctive levetiracetam (LEV) treatment in children and adolescents (4-16years old) with uncontrolled partial-onset seizures. Patients received adjunctive LEV 20-60mg/kg/day (n=64) or placebo (n=34) for 12weeks. The Achenbach Child Behavior Checklist (CBCL) and portions of the Child Health Questionnaire-Parent Form 50 (CHQ-PF50) were used to assess behavioral and emotional functioning at baseline and end of the treatment period. Worsening of the mean CBCL Aggressive Behavior score occurred for LEV but not placebo, leading to similar results for Externalizing Syndromes and Total Problems (all P<0.05 vs placebo). The change in the CBCL Activities Competence score favored LEV (P<0.05). These results are in line with the known safety profile of LEV.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Anticonvulsants / therapeutic use*
  • Behavioral Symptoms* / diagnosis
  • Behavioral Symptoms* / drug therapy
  • Behavioral Symptoms* / etiology
  • Checklist
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Epilepsies, Partial / complications*
  • Epilepsies, Partial / drug therapy*
  • Female
  • Humans
  • Levetiracetam
  • Male
  • Mood Disorders* / diagnosis
  • Mood Disorders* / drug therapy
  • Mood Disorders* / etiology
  • Piracetam / analogs & derivatives*
  • Piracetam / therapeutic use
  • Psychiatric Status Rating Scales
  • Surveys and Questionnaires

Substances

  • Anticonvulsants
  • Levetiracetam
  • Piracetam