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A Randomized, 6-Week Double-Blind, Placebo-Controlled Study With an Optional 24-Week Open-Label Extension to Evaluate the Safety and Tolerability of Flexible Doses of Extended Release OROS® Paliperido...

Update Il y a 4 ans
Reference: EUCTR2004-000326-70

A Randomized, 6-Week Double-Blind, Placebo-Controlled Study With an Optional 24-Week Open-Label Extension to Evaluate the Safety and Tolerability of Flexible Doses of Extended Release OROS® Paliperidone in the Treatment of Geriatric Subjects With Schizophrenia

Woman and Man

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Extract

The primary objective of the study is to evaluate the safety and tolerability of flexible doses of Extended Release (ER) OROS® paliperidone (3 to 12 mg/day) as compared with placebo in subjects with schizophrenia who are 65 years of age or older. The primary objective of the open-label extension is the long-term assessment of safety and tolerability of ER OROS paliperidone (3 to 12 mg/day) in subjects diagnosed with schizophrenia.

Inclusion criteria

  • Schizophrenia

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