The purpose of this study is to determine that the efficacy of the sustained release (SR) formulation of quetiapine (Seroquel) is not inferior to the immediate release (IR) formulation. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
454
The proportion of patients who discontinue study treatment due to lack of efficacy or whose positive and negative syndrome scale (PANSS) total score increases 20% or more
Time frame: from randomisation to any visit
The change in PANSS total score
Time frame: from randomization to week 6
The change in PANSS positive, negative and general psychopathology symptoms subscale scores respectively
Time frame: from randomization to week 6
The proportion of patients with a Clinical Global Impressions - Improvement (CGI-I) score greater than or equal to 4
Time frame: at week 6
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