The Paliperidone ER Observational Study of Economic, Functional, and Clinical Outcomes in Patients With Schizophrenia

• Status: Terminated
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine the long-term economic, functional and clinical outcomes in schizophrenia patients who require a change in antipsychotic treatment, and are changed to either paliperidone extended release (ER) or another oral atypical antipsychotic agent (AAP) including aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
• Treatments: Antipsychotic Agents; Paliperidone Palmitate

Criteria

Inclusion Criteria:

• Must have a clinical diagnosis of schizophrenia for at least 1 year prior to screening

• Had been receiving treatment with antipsychotics, but is judged to be a candidate for changing antipsychotic on the basis of either persistent symptoms or continuing side effects

• Treating physician has determined, before the patient enters the study, that starting paliperidone extended release (ER) or another of at least two possible atypical antipsychotics (AAPs) is an appropriate treatment for the patient

• Likely to be managed as outpatient

• Must have signed the informed consent form for DNA pharmacogenomic

Exclusion Criteria:

• Have mental retardation, dementia, bipolar, schizoaffective disorder, schizophreniform disease, other Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) psychiatric disorders or deteriorating neurological illnesses as determined by clinical evaluation

• Established treatment-resistant schizophrenia, defined as those who have had treatment failures with adequate trials of two second generation atypicals, previous treatment with clozapine, or 4 or more hospitalizations in the last 12 months

• History of recent violence or at immediate risk of suicide, or harming self or others, or of causing damage to property, in the judgment of the investigator

• Patients who are unable to swallow the medication whole

• History or circumstances that may increase the risk of occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including bradycardia, hypokalemia or hypomagnesemia, concomitant use of drugs that prolong the QTc interval, or presence of congenital long QT syndrome

• Pregnant (as confirmed by urine pregnancy test performed at baseline), planning to become pregnant, or breast-feeding.