NCT00761579

Paliperidone Extended Release(ER) Effectiveness Study to Evaluate the Objective Symptom Change and Symptomatic Remission

An Open-Label Prospective, Non-Comparative Study To Explore The Tolerability, Safety and Effectiveness Upon Transition to Paliperidone Slow-Release Tablet in Schizophrenic Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety and efficacy 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).

Detailed description

This is an open-label, prospective (study following participants forward in time), single arm, and non-comparative study of paliperidone Extended Release(ER) in participants with schizophrenia (after switching from the existing drug to paliperidone ER). The total study duration will be approximately of 48 weeks per participant. The study consists of 2 parts: Screening (that is, 14 days before study commences on Day 1); Treatment (single-oral dose of paliperidone for 48 weeks, dose ranging from 3 to 12 milligram). Efficacy of the participants will primarily be evaluated by Positive and Negative Syndrome Scale. Participants' safety will be monitored throughout the study.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Paliperidone	Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg), 6 mg or 9 mg for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-10-01
• Completion: 2010-12-01
• First posted: 2008-09-29
• Last updated: 2014-06-03
• Results posted: 2014-06-03

Locations

8 sites across 1 country: South Korea