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| |  CINP: Quetiapine, Divalproex Combination Better for Bipolar Disorder in Teens than Divalproex Alone By Danny Kucharsky Special to DG News MONTREAL, QC -- June 26, 2002 -- The combination of quetiapine and divalproex is more effective at reducing manic, depressive and psychotic symptoms associated with bipolar disorder in adolescents than divalproex alone, researchers report. The study aimed at evaluating the efficacy, tolerability and safety of quetiapine as adjunctive therapy to divalproex sodium in teens with bipolar disorder, who were hospitalized for a mixed or manic episode. Results were presented here June 25th at the 23rd Collegium Internationale Neuro-Psychopharmacologicum Congress. In the six-week, double-blind, placebo-controlled study, 30 manic or mixed bipolar I adolescents (aged 12 to 18) received an initial divalproex dose of 20 mg/kg and were randomized to quetiapine (n=15) or placebo (n=15). Patients were titrated from a starting dose of quetiapine 25 mg twice daily to 450 mg/day by Day 7. Twenty-two patients completed the 42-day study. Both treatment groups demonstrated a significant reduction in manic, depressive and psychotic symptoms. But there was a significantly greater anti-manic response rate in the divalproex/quetiapine group than in the divalproex/placebo group, noted investigator Dr. Melissa P. DelBello of the Bipolar and Psychotic Disorders Research Program, Department of Psychiatry, University of Cincinnati College of Medicine in Ohio. Response rate (reduction of 50 percent or more from baseline in Young Mania Rating Scale [YMRS] last observation carried forward) was significantly greater in the divalproex/quetiapine group vs. the divalproex/placebo group (p=0.03). For mania, there was an 87 percent response rate in the divalproex/quetiapine group compared with 47 percent in the divalproex/placebo group, using the Clinical Global Impression (CGI) Scale, p<0.05. There was a significantly greater reduction in YMRS, Childhood Depression Rating Scale (CDRS) and Positive and Negative Syndrome Scale-Positive subscale (PANSS-P) in the divalproex and quetiapine group compared to the divalproex and placebo group (Fisher’s exact test, p=0.03). Quetiapine was safe and well tolerated when used as adjunctive therapy. The most common adverse events were sedation (33 percent divalproex and placebo vs. 80 percent divalproex and quetiapine), nausea (40 percent vs. 27 percent) and headache (47 percent in both groups). There were no significant group differences in change from baseline to endpoint in extra-pyramidal symptom measures, QTc interval, thyroid-stimulating hormone levels, haematocrit, white blood cell count or weight. The investigators suggested further study evaluating the efficacy, safety and tolerability of quetiapine in a larger sample population of patients with bipolar disorder is warranted. The research was supported by AstraZeneca Pharmaceuticals.
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