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

Schizophrenia Clinical Trial

Official title: Early Prediction of Clinical Response, Metabolic Change, and Pharmacokinetics in Taiwanese Patients With Schizophrenia Patients Treated by Paliperidone ER: an Open-Label Study

Status Completed

Clinical Trial 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

Clinical Trial Description

Patients diagnosed with schizophrenia or schizoaffective disorders will be enrolled in the 6-week trial. Eligible patients will receive 9mg paliperidone ER first. Then, the dosage of paliperidone could be adjusted two weeks later according to clinical judgement. They will be followed and receive assessment of pharmacokinetics, metabolic parameters ( lipid profiles, glucose, insulin, adiponectin, leptin, and prolactin, etc.), and the treatment response. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

• NCT number: NCT02075528
• Study type: Interventional
• Source: Taipei City Hospital
• Status: Completed
• Phase: Phase 4
• Start date: July 2009
• Completion date: July 2012