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Quetiapine Appears to be Equal in Efficacy to Divalproex in Treating Adolescent Mania: Presented at AACAP

By Paula Moyer

WASHINGTON, DC -- October 25, 2004 -- The atypical antipsychotic quetiapine (Seroquel) is at least as effective as divalproex (Depakote) in treating adolescent mania, say researchers.

Presenting study findings here October 22^nd at the 51^st annual meeting of the American Academy of Child and Adolescent Psychiatry, co-investigator Robert Kowatch, MD, a professor of psychiatry at University of Cincinnati College of Medicine in Cincinnati, Ohio, said, "This is the first head-to-head study of an atypical antipsychotic and a standard mood stabilizer in adolescent bipolar disorder." The principal investigator was Melissa P. DelBello, MD, also at University of Cincinnati.

The investigators wanted to know if quetiapine was at least as effective as divalproex, and they defined "at least as effective" as effectiveness of at least 80% of that for divalproex. The study involved 50 adolescents with bipolar disorder type 1, who were experiencing either a manic or mixed episode. The subjects were then randomized to receive either divalproex or quetiapine for a 28-day double-blind study. Those in the quetiapine group received up to 600 mg per day, and those in the divalproex group received 80 to 120 micrograms/mL of valproic acid per serum concentration.

When assessed by the Young Mania Rating Scale (YMRS), those in the divalproex group had a YMRS score reduction averaging 19.5 ± 2.4. For those in the quetiapine group, the average score reduction was 22.4 ± 2.4. For both, the difference from baseline was statistically significant (P < .001 for each). Because of the change in YMRS score in the divalproex group, the investigators decided that the average score for the quetiapine group needed to be within 4 points of the divalproex score in order to meet the "at least as effective threshold." The difference between the two groups' average endpoint scores was 3.3 ± 3.4 (95% CI, -3.5, 10.1).

The response rate, defined by a Clinical Global Impression score of less than 2, was 84% in the quetiapine group, compared to 56% for the divalproex group (P = .03). The groups had similar rates of adverse events, which consisted of sedation, occurring in 60% of the quetiapine patients and 36% of the divalproex patients; dizziness, which occurred in 36% patients in each group; and gastrointestinal upset, which occurred in 24% of the quetiapine patients and 28% of the divalproex patients.

"The findings suggest that quetiapine may actually be more effective than divalproex for the treatment of acute mania in bipolar disorder," said Dr. Kowatch. "However, since we weren't looking for superiority of quetiapine, that question will have to be studied further."

[Presentation title: A double-blind comparison of divalproex versus quetiapine for adolescent mania. Abstract C70]

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