A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness and safety of Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) Paliperidone compared to placebo in patients with Schizophrenia. Olanzapine will be used as a reference drug in the study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.
• Treatments: Olanzapine; Paliperidone Palmitate

Criteria

Inclusion Criteria:

• Patients who have given their own consent in writing to participate in the study

• Patients diagnosed with schizophrenia according to the diagnostic criteria of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 295.30, 295.10, 295.20, 295.90, 295.60)

• Patients who have acute symptoms of schizophrenia

• Both inpatients and outpatients are acceptable

Exclusion Criteria:

• A DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) of a mental disease diagnosis other than schizophrenia

• A DSM-IV diagnosis of substance-related disorder (except nicotine dependence and caffeine dependence) within 180 days before the screening test

• Total PANSS (Positive and Negative Syndrome System) score at the screening test <70 or >120

• Patients treated with three or more types of antipsychotic within 28 days before the screening test

• Parkinson's disease (except for those with drug-induced extra pyramidal symptoms)

• Patients with a complication of or a past history of cerebrovascular accident

• Patients with a complication of or a past history of diabetes mellitus