New placebo-controlled clinical study examines the effectiveness of Divalproex Extended Release for the treatment of childhood-onset bipolar disorder.
A review of: Wagner, Karen, Redden, Laura, Kowatch, Robert, Wilens, Timothy, Segal, Scott, Chang, Kiki, Wozniak, Patricia, Vigna, Namita, Abi-Saab, Walid, & Saltarelli, Mario (2009). A Double-Blind, Randomized, Placebo-Controlled Trial of Divalproex Extended-Release in the Treatment of Bipolar Disorder in Children and Adolescents. Journal of the American Academy of Child & Adolescent Psychiatry DOI: 10.1097/CHI.0b013e31819c55ec NOTE: the DOI provided by the JACCAP can not be found by DOI.org.
In an upcoming issue of the Journal of the American Academy of Child and
Adolescent Psychiatry Dr. Karen Dinnen Wagner from the Department of Psychiatry at University of Texas and her colleagues report the findings of a randomized, placebo-controlled study of the effectiveness and safety of Divalproex Extended Release for the treatment of bipolar disorder in children and adolescents.
Although there are a number of differences between adult and child bi-polar disorder, and the dramatic increases in diagnoses of bipolar disorder in children is a highly controversial and debated topic, in general terms children with bipolar disorder show frequent and rapid changes between periods of depression and periods of mania. The periods of depression and mania are usually very severe, so that the diagnosis of bipolar does not apply to simply “very moody” or irritable kids. True childhood-onset bipolar disorder is a very serious condition that, if untreated, is associated with several negative outcomes including high risk of suicidal behaviors.
Currently, Divalproex is often used “off-label” (without FDA approval) for the treatment of bipolar in children. This practice reflects findings from a few ‘open label’ studies (studies in which the patients know that they are taking the medication and often no placebo group is included). Unfortunately, open label studies do not tell us whether the observed positive effects of the drug is truly due to the drug or to the expectation that the drug will work (“the placebo effect”). Therefore, to properly assess for the effectiveness of this drug in children and adolescents, the authors randomly assigned 151 children with bipolar (age 11 to 17) disorder to receive Divalproex or to receive a placebo (e.g., a sugar pill). The patients did not know whether they were taking the placebo or the actual drug.
There was also a modest reduction of symptoms after 6 months, but this did not include the placebo drug. Therefore, given the findings of the 28-day trial, the reduction in symptoms observed at after six months is likely due to the placebo effect and not to the drug. The authors conclude:
This is the first report of a multicenter double-blind, randomized, placebo-controlled trial of divalproex ER in the treatment of bipolar I disorder, mixed or manic, in children and adolescents (aged 10Y17 years). There was no statistically significant difference between the divalproex ERYtreated patients and the placebo-treated patients on the primary efficacy measure or secondary measures. At the present time, based on the results of this study, there is not evidence to support the use of divalproex ER in the treatment of youths with bipolar I disorder, manic or mixed state. Because this is the only reported double-blind placebo-controlled trial of divalproex ER in youths with bipolar disorder, it would be reasonable to conduct another controlled trial to confirm or refute the findings from this study.
Please do not make any changes to your child’s medication regime without consulting with your health care provider.
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