New Data on SEROQUEL XR(TM) in Treatment of Both Major Depressive Disorder and Generalized Anxiety Disorder Presented at APA Annu...(allel-group maintenance study 787 patien...),Health

were randomized to SEROQUEL XR or placebo and dose-adjusted as

clinically indicated. The mean daily dose of study drug at

randomization (last open-label dose) was similar for the SEROQUEL XR

group (176.6 [95.5] mg/day) and the placebo group (177.9 [90.8]

mg/day). In total, 89.0% (n=348) of SEROQUEL XR patients were receiving

the same doses at study end as at open-label baseline, 5.1% (n=20) were

receiving a higher dose, and 5.9% (n=23) a lower dose. The risk of a

depressed event was significantly reduced for SEROQUEL XR compared with

placebo suggesting increased time to event (HR = 0.34 [0.25, 0.46];

p<0.001). In total, 55 (14.2%) SEROQUEL XR-treated patients and 132

(34.4%) placebo-treated patients experienced a depressed event. During

the randomized phase, mean changes in MADRS were 0.15 versus 2.03

(p<0.001), and mean changes in Clinical Global Impression-Severity

(CGI-S)(+) were -0.03 versus 0.23 (p<0.001) for SEROQUEL XR versus

placebo, respectively. Open label adverse events (AEs) were similar to

previous experience with SEROQUEL XR. The most common AEs (greater than

or equal to 5% in the SEROQUEL XR group) occurring during the

randomized treatment phase were weight increased, nasopharyngitis,

headache, dizziness, insomnia, and diarrhea.(2)

SEROQUEL XR GAD Clinical Studies

In the SEROQUEL XR clinical development program in GAD, short-term studies (Studies 9, 10 and 11) used the Hamilton Rating Scale for Anxiety (HAM-A)(++) as the primary assessment of anxiety symptoms.(13) In the long-term study (Study 12), the primary assessment was time from randomization to an anxiety event.(5) Doses of 50 mg, 150 mg and 300 mg of SEROQUEL XR were studied in the GAD program.(4-5,13-14) While treatment for GAD typically includes an antidepressant, a
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