Seroquel

[Quetiapine]

(1) In a 6-week, placebo-controlled trial (n= 361) involving 5 fixed doses of SEROQUEL (75, 150, 300, 600 and 750 mg/ day on a tid schedule), the 4 highest doses of SEROQUEL were generally superior to placebo on the BPRS total score, the BPRS psychosis cluster and the CGI severity score, with the maximal effect seen at 300 mg/ day, and the effects of doses of 150 to 750 were generally indistinguishable. SEROQUEL, at a dose of 300 mg/ day, was superior to placebo on the SANS.

(2) In a 6-week, placebo-controlled trial (n= 286) involving titration of SEROQUEL in high (up to 750 mg/ day on a tid schedule) and low (up to 250 mg/ day on a tid schedule) doses, only the high dose SEROQUEL group (mean dose, 500 mg/ day) was generally superior to placebo on the BPRS total score, the BPRS psychosis cluster, the CGI severity score, and the SANS.

(3) In a 6-week dose and dose regimen comparison trial (n= 618) involving two fixed doses of SEROQUEL (450 mg/ day on both bid and tid schedules and 50 mg/ day on a bid schedule), only the 450 mg/ day (225 mg bid schedule) dose group was generally superior to the 50 mg/ day (25 mg bid) SEROQUEL dose group on the BPRS total score, the BPRS psychosis cluster, the CGI severity score, and on the SANS.

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Examination of population subsets (race, gender, and age) did not reveal any differential responsiveness on the basis of race or gender, with an apparently greater effect in patients under the age of 40 compared to those older than 40. The clinical significance of this finding is unknown.

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