In a longer-term trial, clinically stable adult outpatients (n=171) meeting DSM-IV criteria for schizophrenia who remained stable following 16 weeks of open label treatment with flexible doses of SEROQUEL XR (400-800 mg/day) were randomized to placebo or to continue on their current SEROQUEL XR (400-800 mg/day) for observation for possible relapse during the double-blind continuation (maintenance) phase. Stabilization during the open label phase was defined as receiving a stable dose of SEROQUEL XR and having a CGI-S ≤ 4 and a PANSS score ≤ 60 from beginning to end of this open-label phase (with no increase of ≥ 10 points in PANSS total score). Relapse during the double-blind phase was defined in terms of a ≥ 30% increase in the PANSS Total score, or CGI-Improvement score of ≥ 6, or hospitalization due to worsening of schizophrenia, or need for any other antipsychotic medication. Patients on SEROQUEL XR experienced a statistically significant longer time to relapse than did patients on placebo.

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