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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag Ltd.,Thailand
• Treatments: Paliperidone Palmitate

Criteria

Inclusion Criteria:

• Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self)

• Participants unsatisfied with their previous treatment

• Previously or currently on oral atypical antipsychotics

Exclusion Criteria:

• Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities

• History or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body)

• History of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)

• Pregnant or breast-feeding female

• Participation in an investigational drug trial within 30 days prior to selection