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Divalproex sodium for pediatric mixed mania: a 6‐month prospective trial
Author(s) -
Pavuluri Mani N,
Henry David B,
Carbray Julie A,
Naylor Michael W,
Janicak Philip G
Publication year - 2005
Publication title -
bipolar disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.285
H-Index - 129
eISSN - 1399-5618
pISSN - 1398-5647
DOI - 10.1111/j.1399-5618.2005.00204.x
Subject(s) - young mania rating scale , mania , tolerability , medicine , bipolar i disorder , bipolar disorder , clinical global impression , placebo , psychology , adverse effect , psychiatry , mood , alternative medicine , pathology
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.