NCT01387542

Safety and Efficacy Study of Paliperidone Extended Release (ER) Among Thai Schizophrenia Participants

An Open-label, PRospective Study to Evaluate Social Function and Overall Improvement of Paliperidone ER Treatment in Thai Schizophrenia PatieNT (PRESENT)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Janssen-Cilag Ltd.,Thailand · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (ER) treatment in Thai schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants.

Detailed description

This is an open-label (all people know the identity of the intervention), non-randomized (the study drug is not assigned by chance) study to evaluate the efficacy and safety of paliperidone ER in adult Thai schizophrenia participants. The study consists of a screening phase and an open-label treatment phase. Study duration will be 10 weeks and participants can either be inpatient or outpatient. The recommended paliperidone ER starting and maintenance dose will be 6 milligram (mg) per day for most participants. Throughout the study, flexible dosing ranging from 3 to 12 mg per day may be used at the discretion of the investigator. Throughout the study, participants will be evaluated for efficacy using clinician rating (Clinical and Global Impressions-Severity \[CGI-S\] scale, and Personal and Social Performance Scale \[PSP\]) scales. Safety of the participants will be monitored.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Paliperidone extended release (ER)	Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2011-07-04
• Last updated: 2013-03-05
• Results posted: 2013-03-05

Locations

2 sites across 1 country: Thailand