Acutely ill, hospitalized patients with schizophrenia showed significant improvement in symptoms after taking Ortho-McNeal's (a Johnson & Johnson company) Invega (paliperidone) extended-release tablets compared to AstraZeneca's Seroquel (quetiapine) and placebo. Symptom improvement was observed with Invega as early as five days into therapy and continued through the end of the two-week study period, according to preliminary data presented at the 20th Annual US Psychiatric and Mental Health Congress in Orlando, Florida.
The primary endpoint was the change in the total Positive and Negative Syndrome Scale (PANSS) score over the first two weeks of the study. The results showed that Invega achieved a significant reduction of symptoms of acutely-ill, hospitalized patients, compared to SEROQUEL and placebo after two weeks of treatment (p < less than > 0.001).
The primary efficacy endpoint was total change in PANSS score from baseline to the end of the monotherapy phase (day 14). The average PANSS score at baseline was 102.8 (plus or minus 13.1) for the Invega group, 101.6 (plus or minus 13.5) for the Seroquel arm, and 103.8 (plus or minus 15.7) for the placebo group. At the end of the monotherapy phase (day 14), the change in the total score from baseline was: -23.4 (1.8) for Invega, - 17.1(1.8) for Seroquel and -15.0 (2.2) for placebo, with Invega showing a significant reduction in symptoms over both Seroquel (p < less than > 0.001) and placebo (p < less than > 0.001).
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