Divalproex sodium for pediatric mixed mania: a 6-month prospective trial.
OBJECTIVE
This prospective 6-month open trial examined the effectiveness and safety of divalproex sodium (DVPX) in pediatric mixed mania.


METHODS
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 (> or =50% change from baseline YMRS score and < or =40 score on CDRS-R at the end of study) was 73.5%. The remission rate (> or =50% change from baseline on YMRS, < or =40 on CDRS-R, CGI-BP-Improvement subscale of < or =2, and > or =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.


CONCLUSIONS
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.
Pavuluri
Mani N
MN
Pediatric Mood Disorders Research Program, Department of Psychiatry, University of Illinois at Chicago, Chicago, IL 60612, USA. mpavuluri@psych.uic.edu
Henry
David B
DB
Carbray
Julie A
JA
Naylor
Michael W
MW
Janicak
Philip G
PG
D000293:Adolescent; D018692:Antimanic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy*; D002648:Child; D005260:Female; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D014635:Valproic Acid / Q000009:adverse effects / Q000627:therapeutic use*
D018692:Antimanic Agents; D014635:Valproic Acid