Large Controlled Trial of Widely Used Mood Stabilizers Demonstrates Efficacy in Pediatric Bipola...( Shows Treatment Significan...),Health

Shows Treatment Significantly Effective at Eight Weeks

CINCINNATI, Oct. 26 /PRNewswire/ -- In the largest pediatric study of its kind on mood stabilizers, scientists from Cincinnati Children's Hospital Medical Center and two other centers demonstrated that divalproex sodium (Depakote(R)) has efficacy for significantly improving symptoms of bipolar I disorder in children and adolescents, according to results presented today at the annual meeting of the American Academy of Child and Adolescent Psychiatry in Boston.

Many psychiatric medications prescribed for children and adolescents have not been indicated by the FDA for pediatric use. Making sure these drugs are effective and safe has been an important goal of pediatric psychiatry researchers as well as gaining FDA indications for appropriate use in children.

"Divalproex and lithium are the most widely used mood stabilizers for children and adolescents diagnosed with bipolar disorder," said Robert A. Kowatch, M.D., Ph.D., a child and adolescent psychiatrist specializing in bipolar and other mood disorders at Cincinnati Children's. "Our study now proves that these agents definitely work, which may give clinicians and families peace of mind."

Dr. Kowatch presented the eight-week, acute efficacy results from the Pediatric Bipolar Collaborative Mood Stabilizer Trial, which also included a second, 16-week phase. The investigation is the first controlled trial to test and compare lithium and divalproex versus placebo for six months, the largest trial of lithium and divalproex to date and first to demonstrate efficacy for divalproex in children aged 7 to 17 years, diagnosed with bipolar I disorder, mixed or manic, based on standardized criteria.

Specifically, at the end of an eight-week treatment phase, patients receiving divalproex significantly decreased their average scores (p<0.01 compared to placebo) on the study's primary outcome measure for manic symptom severity, the Youn
'/>"/>