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Title: Adolescents Bipolar along with Disruptive Behavior Respond Equally Well to Quetiapine and Divalproex: Presented at AACAP

"Adolescents Bipolar along with Disruptive Behavior Respond Equally Well to Quetiapine and Divalproex: Presented at AACAP"

By Paula Moyer TORONTO, CANADA -- October 31, 2005 -- The atypical antipsychotic quetiapine (Seroquel) and the anticonvulsant divalproex (Depakote) achieve similar efficacy rates in adolescents who have aggressive symptoms attributable to bipolar disorder or disruptive behavior disorder, according to findings presented here at the joint annual meeting of the American and Canadian Academies of Child and Adolescent Psychiatry (AACAP/CACAP). "Few studies have evaluated treatments for this population," said principal investigator Drew H. Barzman, MD, Assistant Professor of Pediatrics and Psychiatry, Division of Bipolar Disorders Research, University of Cincinnati in Cincinnati, Ohio. He stressed that adolescents with bipolar disorder often also have a disruptive behavior disorder, such as oppositional defiant disorder or attention deficit hyperactivity disorder (ADHD). Although divalproex had shown promise for mood lability and temper, there is limited information on whether an atypical antipsychotic would reduce aggression in such patients, Dr. Barzman said. The investigators recruited 50 adolescents, 12 to 18 years old, who were diagnosed with bipolar I disorder and hospitalized with a manic or mixed episode. Patients were randomized to received quetiapine or divalproex in a double-blind manner for 28 days. The investigators used patients' records in the post-hoc analysis if they scored 14 or more on the Positive And Negative Symptoms Score (PANSS) Excited Component (EC) and had a score of 4 or more on at least one of these items. Among the 36 patients who had both bipolar disorder and a disruptive behavior disorder, 33 (92%) were able to be included based on the PANSS EC criteria. Those in the quetiapine group received an initial dose of 100 mg per day on day 1, increased to 400 mg per day on days 4 through 7 and up to 600 mg per day afterward, with the dose given in either one dose or two divided doses. Divalproex was give at a dose of 20 mg/kg at bedtime. Two psychiatrists who were not blinded and who did not perform efficacy or tolerability ratings monitored the patients on divalproex and adjusted the dose as necessary. These adjustments ensured that patients had a valproic acid serum level in the therapeutic range, 80 to 120 mg/dL. In the quetiapine group, six patients had comorbid conduct disorder; 11 had oppositional defiant disorder, and five had ADHD. In the divalproex group, 7 had conduct disorder, 11 had oppositional defiant disorder, and six had ADHD. At the study's end, both groups had significant improvements on the PANSS EC, with an average score change from 18.8 to 10.8 at the study's end among those on quetiapine, and a change from 20.6 at baseline to 13.3 at the study's end in the divalproex group (P < .0001 for each). The groups had similar improvements on a week-by-week basis, with neither group showing response earlier than the other. "No patients discontinued either treatment due to an adverse event," said Dr. Barzman. He noted that, although adverse events occurred commonly, with 203 such events occurring during the study period, they were typically mild and transient, consisting of sedation or fatigue, gastrointestinal discomfort, or headache. Although placebo-controlled trials will be necessary, quetiapine may be a useful way to treat adolescents who live with the confluence of bipolar disorder and disruptive behavior disorders, Dr. Barzman said. He noted that the use of an anticonvulsant like divalproex is more common. The study was funded by AstraZeneca Pharmaceuticals, which manufactures Seroquel. [Presentation title: Treatment for Aggression in Bipolar Adolescents with Disruptive Behavior Disorders. Abstract C-35]

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