NCT01362439

Paliperidone Extended Release in Schizophrenia Participants With Duration of Illness Less Than 10 Years

Efficacy and Tolerability of Flexible Doses of Paliperidone ER in Symptomatic Subjects With Schizophrenia With Duration of Illness < 10 Years

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Janssen-Cilag S.p.A. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (ER) in symptomatic participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) who were receiving treatment with any oral (having to do with the mouth) antipsychotic medication and who needed to be switched to paliperidone ER from the current oral antipsychotic therapy due to insufficient efficacy or due to side effects.

Detailed description

This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center) and non-comparative study of paliperidone ER in participants with schizophrenia who have a previous history of bad adherence to the antipsychotic treatment because of insufficient efficacy and side-effects. All the eligible participants will receive a dose of paliperidone ER in range of 3 to 12 milligram (mg) orally (taken by mouth; to be swallowed) once daily for 13 weeks. Efficacy and safety will primarily be evaluated by Positive and Negative Syndromes Scale (PANSS) and Extrapyramidal Symptom Rating Scale (ESRS), respectively. Participants' safety will be monitored throughout the study.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Paliperidone ER	Participants will be administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose will be increased or decreased as per Investigator's discretion.

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2011-05-30
• Last updated: 2013-06-05
• Results posted: 2013-06-05