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Lithium, Divalproex Similarly Efficacious in Paediatric Bipolar Disorder: Presented at AACAP

By Paula Moyer

MIAMI BEACH, FL -- October 27, 2003 -- Children and adolescents with bipolar disorder respond well to combination therapy consisting of lithium and divalproex (Depakote), according to principal investigator Robert L. Findling, MD.

"There is a misconception that children do not respond as well as adults to mood stabilisers," said Dr. Findling, the director of child and adolescent psychiatry at University Hospitals of Cleveland, where he is also on the faculty at Case Western Reserve University. "However, when children are taken off of medications that may destabilise their bipolar disorder, they actually have a better response than do adults."

While depression is the predominant mood excursion in adult bipolar disorder, manic and hypomanic episodes are the most common events in children and adolescents with this condition, Dr. Findling said. He presented his and his colleagues' results here October 17^th at the 50^th Anniversary Meeting of the American Academy of Child and Adolescent Psychiatry.

In the first phase of the research the investigators enrolled 139 children and adolescents, who ranged form five to 17 years old and an average of 10.8 ± 3.5 years old. The subjects had been diagnosed with either bipolar I or bipolar II disorder and had experienced either a hypomanic or a manic episode within three months prior to enrolment. Among the subjects, 95 (68.3 percent) had comorbid attention deficit hyperactivity disorder (ADHD), 39 (28.1 percent) had oppositional defiant disorder, and 17 (12.2 percent) had conduct disorder.

All subjects were treated for up to 20 weeks with the combination regimen. The outcomes measures that the investigators used consisted of the Children's Depression Rating Scale-revised (CDRS-R), the Young Mania Rating Scale-Children (YMRS-C), and the Children's Global Assessment Scale (CGAS). Those who responded for four consecutive weeks were then withdrawn for enrolment in a succeeding trial, with response having been defined as a CDRS-R score of less than 40, a YMRS-C score of less than 12.5, and a CGAS score of more than 51.

The mean length of treatment was 10.7 ± 5.4 weeks. The investigators documented a significant improvement in all three outcome measures by the end of week 4 of treatment (p < -.001). Among the participants, 60 (43 percent) met the response criteria for the succeeding study, and 21 (15.1 percent) withdrew due to medication intolerance.

In the succeeding study, the 60 patients who continued on were randomised to monotherapy with either lithium or divalproex, with treatment continuing for up to 76 weeks. The investigators wanted to see if either therapy had advantages over the other as a maintenance therapy in early-onset bipolar disorder.

The two agents were similar in their ability to protect against a mood event, according to Dr. Findling. For those on lithium, the median length of time until such an event was 114 days (SE + 57.4 days). The median length of time for those on divalproex was 112 days (SE +56.0 days) ( p= .55). The median lengths of time until medication was discontinued for any reason were similar for two groups, 91 days for lithium (SE 30.1 days) and 56 days for divalproex (19.9 days) (log rank = 0.13, p-0.72).


[Study titles: Combination Lithium and Divalproex Sodium Treatment in Juvenile Bipolarity. Abstract C24; Lithium Versus Divalproex Sodium Maintenance Treatment in Bipolar Disorder. Abstract C25]

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