- Home>
- Specialty Care>
- Psychiatry>
- Summary and Comment
What’s Good for Geese May Not Be Good for Goslings: The Case of Oxcarbazepine
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 diphenhydramine was allowed for agitation. Twenty oxcarbazepine recipients and 23 placebo recipients discontinued (34% vs. 41%). Unsatisfactory response led to discontinuation in 10% of oxcarbazepine recipients and 25% of placebo recipients; adverse events led to discontinuation in 19% and 4%, respectively.
The researchers used intent-to-treat analyses involving all randomized cases with at least one post-randomization assessment. They found no treatment-group differences in outcomes on continuous or categorical measures. Approximately 40% of oxcarbazepine recipients in both age groups were responders. Placebo response was lower in the younger than in the older age group (17% vs. 41%). Side effects included nausea, dizziness, diplopia, and rash.
Comment: In this well-conducted study, oxcarbazepine was not beneficial in children and adolescents. Research support remains limited for using drugs that work well in adults with mania to treat children with bipolar disorder, and these results argue for additional pediatric age-specific treatment studies.
— Barbara Geller, MD
Published in Journal Watch Psychiatry July 24, 2006
Citation(s):
Wagner KD et al. A double-blind, randomized, placebo-controlled trial of oxcarbazepine in the treatment of bipolar disorder in children and adolescents. Am J Psychiatry 2006 Jul; 163:1179-86.
- Original article (Subscription may be required)
- Medline abstract (Free)