Quetiapine with lithium or divalproex for the treatment of bipolar mania: a randomized, double-blind, placebo-controlled study.

Autor: Sachs, G, Chengappa, KNR, Suppes, T, Mullen, JA, Brecher, M, Devine, NA, Sweitzer, DE
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Zdroj: Bipolar Disorders; Jun2004, Vol. 6 Issue 3, p213-223, 11p
Abstrakt: Objective: Evaluate the efficacy and tolerability of quetiapine (QTP) combined with lithium (Li) or divalproex (DYP) in the treatment of acute mania. Methods: Patients were randomized to 21 days of double-blind treatment with QTP plus Li/DYP, or placebo (PBO) plus Li/DYP. QTP was rapidly dosed up to a maximum of 800 mg/day; Li was dosed to 0.7-1.0 mEq/L; or DVP to 50-100 μg/mL. Results: Fifty-six of 91(61.5%) individuals in the QTP + Li/DVP group compared with 49 of 100 (49%) taking PBO + Li/DVP completed the study. A significantly greater mean reduction in total Young Mania Rating Scale (YMRS) score was observed at end-point in patients receiving QTP + Li/DVP compared with those in the PBO + Li/DVP group (-13.76 versus -9.93; p = 0.021). The response rate (≥50% YMRS improvement) was significantly higher in the QTP + Li/DVP group than in PBO + Li/DVP-treated patients (54.3% versus 32.6%; p = 0.005), as was the proportion of patients achieving clinical remission (YMRS < 12) (45.7% versus 25.8%; p = 0.007). Patients receiving QTP + Li/DVP also had a significantly greater improvement in Clinical Global Impressions-Bipolar (CGI-BP) Severity of Illness scores (-1.38 versus -0.78; p = 0.001). The mean last-week dose of QTP was 584 mg/ day in patients meeting response criteria. Common adverse events (at least 10% and twice the rate of Li/DVP) in the QTP + Li/DVP group included somnolence, dry mouth, asthenia, and postural hypotension. Conclusions: Quetiapine combined with either Li or DYP has superior efficacy compared with Li or DYP monotherapy for treating patients with bipolar mania. Combination therapy was well-tolerated and most adverse events were mild, withdrawal because of adverse events being only 5% compared with 6% on Li or DYP monotherapy. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index
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