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Depakote and Bipolar Disorder - Medscape Article
PHOENIX, ARIZ. -- Between 34% and 46% of children and adolescents with bipolar disorder responded well to one of three commonly used mood stabilizers in the first prospective, randomized comparison trial performed in a pediatric population.
Although all of the drugs -- divalproex sodium, carbamazepine, and lithium -- brought about comparable, measurable improvements, divalproex had the highest response rate, Dr. Robert A. Kowatch said at a meeting of the American Society for Adolescent Psychiatry.
In the intent-to-treat analysis of the 42 children with bipolar I or II disorder, 46% of patients randomized to divalproex sodium (Depakote) responded well, compared with a 34% response rate in both the patients randomized to carbamazepine (Tegretol) and those who received lithium (Lithobid). Response was defined as a Clinical Global Impression scale change of 1 or 2 or a 50% change in the subject's baseline Young Mania Rating Scale score.
Treatment lasted 6 weeks, followed by an 18-week continuation phase, during which therapy could be amended to increase the dosage or to add another mood stabilizer or stimulant or antidepressant as needed.
Of the 32 who completed the initial 6 weeks of the study, 50% responded to divalproex, 44% responded to carbamazepine, and 45% responded to lithium.
"So it is similar to what you see in adult trials -- about half of kids respond," said Dr. Kowatch, director of the Pediatric Bipolar Program at the University of Texas in Dallas.
Prior to this study, there was only one study of mood stabilizer treatment in a pediatric population with bipolar disorder, Dr. Kowatch said. In that study of 25 pediatric patients who received lithium, there was a 46% response rate (J. Am. Acad. Child Adolesc. Psychiatry 37[2]:171-78, 199 .
In Dr. Kowatch's study, subjects treated with divalproex tended to get worse during the first 2-3 weeks of treatment before ultimately responding. Those treated with carbamazepine showed the fastest improvement.
Among patients who responded to divalproex or carbamazepine, most responded by 6 weeks, while some patients on lithium did not respond for 8 weeks. "Clinically it means you might want to give lithium a longer trial," he said.
Only 16 of the 42 subjects (38%) were already on mood stabilizers at the start of the trial. Most of them were on other drugs, however. For example, 80% were on stimulants and about 50% were on antidepressants.
Dr. Kowatch did not propose an explanation for why these children, who met DSM-IV criteria for bipolar disorder while taking part in the study, were not receiving mood stabilizers. But his results suggest that "we are not using mood stabilizers enough."
The medications were all well tolerated, with few adverse effects, he said.
The study began with a 2-week evaluation period when the patients were weaned from whatever medications they were on. The 42 subjects met DSM-IV criteria for a bipolar I (48%) or bipolar II (52%) diagnosis; they had a score greater than 14 on the Young Mania Rating Scale. All were "moderately impaired," nonhospitalized patients, with a mean age of 11 years.
Seventy-one percent of subjects had comorbid attention-deficit hyperactivity disorder (ADHD).
Most had not responded to stimulant treatment prior to the study, but after treatment with a mood stabilizer, 93% responded to the stimulant treatment.
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