Safety Study With Paliperidone ER Extended-Release (ER) Tablets in Geriatric Patients With Schizophrenia

Summary

The primary objective of the study is to evaluate the safety and tolerability of flexible dosages of paliperidone ER as compared with placebo in patients 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 paliperidone ER in patients diagnosed with schizophrenia.

Timeline

Start

2004-08

Primary completion

—

Completion

2005-05

Publications

• Results Tzimos A, Samokhvalov V, Kramer M, Ford L, Gassmann-Mayer C, Lim P, Eerdekens M. Safety and tolerability of oral paliperidone extended-release tablets in elderly patients with schizophrenia: a double-blind, placebo-controlled study with six-month open-label extension. Am J Geriatr Psychiatry. 2008 Jan;16(1):31-43. doi: 10.1097/JGP.0b013e31815a3e7a.

Drugs

Indications