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SEROQUEL XR 150 mg/day, SEROQUEL XR 300 mg/day, or placebo. At Week 6,
all SEROQUEL XR groups had significantly reduced mean MADRS score
versus placebo (-11.07): -13.56 (p<0.05) for 50 mg/day; -14.50
(p<0.001) for 150 mg/day; and -14.18 (p<0.01) for 300 mg/day. By Day
4, all SEROQUEL XR groups significantly reduced mean MADRS score versus
placebo (-3.27): -4.91 (p<0.01) for 50 mg/day; -5.43 (p<0.001) for 150
mg/day; and -5.35 (p<0.001) for 300 mg/day. The most common adverse
events (AEs) (greater than or equal to 5% and double the rate of
placebo in any SEROQUEL XR dose group) were dry mouth, sedation,
somnolence, dizziness, constipation, back pain, irritability, and
myalgia.(1)
-- Study 6 (Poster # NR3-088) -- In a six-week, multicenter, double-blind
study, 446 patients were randomized to receive antidepressant (AD) plus
SEROQUEL XR 150 mg/day, SEROQUEL XR 300 mg/day, or placebo. SEROQUEL XR
300/mg day plus an antidepressant showed statistically significant
advantage versus placebo plus an AD for 1) change in MADRS total score
at Week 6 (-14.70 versus -11.7; p<0.01); 2) improvement in MADRS from
Week 1 onwards; 3) response (58.9% versus 46.2%; p<0.05); and 4)
remission (42.5% versus 24.5%; p<0.01). For SEROQUEL XR 150 mg/day plus
AD, improvements in these variables were not significantly different
versus placebo, except for MADRS improvement at Weeks 1 and 2. The most
common adverse events (AEs) (greater than or equal to 5% and double the
rate of placebo in any SEROQUEL XR dose group) were dry mouth,
somnolence, sedation, dizziness, constipation, fatigue, and weight
increased.(3)
-- Study 5 (Poster # NR3-017) -- In a time-to-event, double-blind,
randomized-withdrawal, par
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