کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
6232892 | 1608157 | 2014 | 9 صفحه PDF | دانلود رایگان |
BackgroundTo evaluate the effectiveness of quetiapine extended release once daily in bipolar depression.MethodsDouble-blind, placebo-controlled study in acutely depressed adults with bipolar I or II disorder, with or without rapid cycling. Patients were randomized to 8 weeks of quetiapine extended release (XR) 300 mg daily monotherapy or placebo. The primary outcome measure was changed from baseline to Week 8 in MADRS total score.ResultsQuetiapine XR 300 mg once daily (N=133) showed signiï¬cantly greater improvement in depressive symptoms compared with placebo (N=137) from Week 1 (p<0.001) through to Week 8 (p<0.001). Mean change in MADRS total score at Week 8 was â17.4 in the quetiapine XR group and â11.9 in the placebo group (p<0.001). Response (â¥50% reduction in MADRS total score) and remission (MADRS total score â¤12) rates at Week 8 were signiï¬cantly higher with quetiapine XR compared with placebo (p<0.001 and p<0.05, respectively). Quetiapine XR improved core symptoms of depression. The most common adverse events associated with quetiapine XR were dry mouth, somnolence, and sedation. Greater weight gain was observed in patients on quetiapine XR relative to placebo.LimitationsFewer patients with bipolar II disorder included, only one ï¬xed dose tested and the lack of an active comparator.ConclusionsQuetiapine XR (300 mg) once daily monotherapy was signiï¬cantly more effective than placebo for treating episodes of depression in bipolar I disorder, throughout the 8-week study, with signiï¬cance observed as early as Day 7. Adverse events were consistent with the known effects of quetiapine.
Journal: Journal of Affective Disorders - Volume 168, 15 October 2014, Pages 485-493