In children and adolescents with bipolar disorder, oxcarbazepine and placebo had similar efficacy.
This manufacturer-sponsored study is the first double-blind, placebo-controlled, randomized trial of oxcarbazepine in the pediatric age group. Indeed, there are few double-blind, placebo-controlled studies of any mood stabilizer in children. The 116 outpatients (age range, 7–18) had DSM-IV bipolar I disorder (manic or mixed phase); the study excluded acutely suicidal or homicidal patients.
The 7-week study included 2 weeks of titration, 4 weeks of maintenance, and 1 week of discontinuation. Flexible dosing was used (maximum dose levels by 2 weeks, 900–2400 mg/day). Randomization was stratified by ADHD comorbidity and by age (7–12 and 13–18). Children stabilized on stimulants for the previous 3 months were allowed to continue them, and diphen…