Large Controlled Trial of Widely Used Mood Stabilizers Demonstrates Efficacy in Pediatric Bipola...(g Mania Rating Scale (YMRS). Fifty-six p...),Health

Date:10/26/2007

g Mania Rating Scale (YMRS). Fifty-six percent of patients in the divalproex group, 41 percent of those in the lithium group and 30 percent of the placebo group experienced a more than 50 percent decrease in their YMRS scores (comparisons by treatment group were: p<0.05 for divalproex vs. placebo, p=0.36 for lithium vs. placebo and p=0.10 for divalproex vs. lithium).

Also, the response rates on the study's other primary outcome measure, the Clinical Global Impressions Ratings (CGI) - improvement score, indicated that 54 percent of the divalproex group, 42 percent of the lithium group and 29 percent of the placebo group improved their CGI scores by one or two points, (p<0.05 for divalproex vs. placebo, p=0.26 for lithium vs. placebo and p=0.27 for divalproex vs. lithium).

The National Institute of Mental Health supported the Pediatric Bipolar Collaborative Mood Stabilizer Trial via a five-year grant. In addition to Cincinnati Children's, other sites involved were Wisconsin Children's Hospital and Case Western Reserve University. In the study, investigators randomly assigned 153 children to receive a placebo, lithium or divalproex. Neither the investigators nor patients knew to which treatment group the patients were assigned at the end of the eight week treatment phase. Those patients who responded to treatment could continue in the double-blind testing for another 16 weeks.

The classic form of the bipolar illness, also know as bipolar I disorder, occurs in children 6 to 17 years. The estimated annual number of for U.S. youths aged 19 years and younger receiving a diagnosis of bipolar disorder is about 1 percent, based on a 2007 NIH-funded analysis finding bipolar diagnoses occurring during 1,003 physician office-based visits by this age group per 100,000 population. Symptoms include severe, explosive mood swings, euphoria, irritable mood, decreased need for sleep without daytime fatigue, pressured speech that is difficult to interrupt, racing thoug
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SOURCE Cincinnati Children's Hospital Medical Center Copyright©2007 PR Newswire. All rights reserved

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