Early Prediction of Clinical Response in Patients With Schizophrenia Treated by Paliperidone ER

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Paliperidone ER is a new psychotropic medication for schizophrenia treatment. The studies of 6-week acute treatment and 52-week maintenance treatment showed positive results in patients with schizophrenia and its clinical improvement may start at Day 4. Some second-generation antipsychotics have been found that using the first 2 weeks' treatment results to predict the fourth or sixth week's treatment response is acceptable.

The primary aim of this study is to investigate:

1. . whether the early prediction model used in other atypicals could also be applied in paliperidone ER.

2. . The changes of metabolic parameters and pharmacokinetics after paliperidone ER treatment in this study

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

Details

• Lead Sponsor: Taipei City Hospital
• Collaborators: Johnson & Johnson Taiwan Ltd; Taipei Institute of Pathology
• Treatments: Paliperidone Palmitate

Criteria

Inclusion Criteria:

• diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)

• a minimal baseline total score of 60 on the PANSS

• those who had not received long-acting antipsychotic injection for the preceding 6 months

• physically healthy and standard clinical laboratory test results within laboratory reference ranges, or if outside the ranges, judged to be clinically insignificant by the investigators.

Exclusion Criteria:

• diagnosis of substance (including alcohol) dependence in the previous 6 months

• a medical condition that could affect absorption, metabolism, or excretion of the study drug

• substantial risk of suicide or violent behavior

• pregnancy or breastfeeding

• documented organic disease of the central nervous system

• unstable or critical untreated medical illness

• history of clozapine treatment in the previous 3 months

• participation in an investigational drug trial in the 30 days before screening.