An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended Release (ER) in Participants With Schizophrenia

Summary

The purpose of this study is to explore tolerability, safety and effectiveness of flexibly dosed paliperidone extended release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) previously unsuccessfully treated with an oral antipsychotic medication.

Timeline

Start

2007-04-25

Primary completion

2009-01-22

Completion

2020-03-04

Outcome

Met primary endpoint

paper For switchers from other than the lack-of-efficacy group, efficacy maintenance after switching to paliperidone ER was confirmed. PMID 24491033 ↗

Publications

• Results Schreiner A, Lahaye M, Peuskens J, Naber D, Dilbaz N, Millet B, Franco MA, Rancans E, Turczynski J, Smeraldi E, Lara E, Neznanov NG. Paliperidone extended-release in patients with non-acute schizophrenia previously unsuccessfully treated with other oral antipsychotics. Expert Opin Pharmacother. 2014 Apr;15(5):593-603. doi: 10.1517/14656566.2014.884071. Epub 2014 Feb 3.

Drugs

Indications