MNP has received research support, acted as a consultant or served as a CME speaker for Abbott, AstraZeneca, Bristol Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Eli Lilly & Co., Pfizer and Shire. JAC has served as a CME speaker for Johnson & Johnson. DBH, MWN and PGJ have no reported conflict of interest.
Divalproex sodium for pediatric mixed mania: a 6-month prospective trial
Article first published online: 17 MAY 2005
Volume 7, Issue 3, pages 266–273, June 2005
How to Cite
Pavuluri, M. N., Henry, D. B., Carbray, J. A., Naylor, M. W. and Janicak, P. G. (2005), Divalproex sodium for pediatric mixed mania: a 6-month prospective trial. Bipolar Disorders, 7: 266–273. doi: 10.1111/j.1399-5618.2005.00204.x
- Issue published online: 17 MAY 2005
- Article first published online: 17 MAY 2005
- Received 8 September 2004, revised and accepted for publication 18 February 2005
- bipolar disorder;
- clinical trial;
- divalproex sodium;
- mood stabilizer;
- pediatric bipolar disorder;
Objective: This prospective 6-month open trial examined the effectiveness and safety of divalproex sodium (DVPX) in pediatric mixed mania.
Method: Thirty-four subjects with a mean age of 12.3 (SD = 3.7) years, DSM-IV diagnosis of a current mixed episode and a baseline Young Mania Rating Scale (YMRS) score >20 were treated with DVPX monotherapy. The primary outcome measures were the YMRS and the Child Depression Rating Scale-Revised. Secondary measures were the Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) and the Children's Global Assessment of Functioning Scale (C-GAS). Measures of safety and tolerability were also administered.
Results: Effect size (Cohen's d) based on change scores from baseline was 2.9 for the YMRS and 1.23 for the CDRS-R. Response rate (≥50% change from baseline YMRS score and ≤40 score on CDRS-R at the end of study) was 73.5%. The remission rate (≥50% change from baseline on YMRS, ≤40 on CDRS-R, CGI-BP-Improvement subscale of ≤2, and ≥51 CGAS score) was 52.9%. Significant improvements (p < 0.001) from baseline were seen for mean scores on all outcome measures (i.e., YMRS, CGI-BP, CDRS-R, and C-GAS). DVPX was safe and well tolerated with no serious adverse events during the 6-month trial.
Conclusion: This study provides evidence for the effectiveness and safety of DVPX in the treatment of pediatric mixed mania over a 6-month period. Placebo-controlled, randomized trials involving larger samples will ultimately shed light on the efficacy of this agent.