NCT02075528

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Taipei City Hospital · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
DRUG	Paliperidone ER	9 mg/d of paliperidone ER was administered during the first 2 weeks, after which the dose was adjusted clinically

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-05-01
• Completion: 2012-07-01
• First posted: 2014-03-03
• Last updated: 2014-03-03

Locations

1 site across 1 country: Taiwan