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

NCT02075528 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2014-03-03

No results posted yet for this study

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

Conditions

Interventions

DRUG

Paliperidone ER

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

Sponsors & Collaborators

  • Johnson & Johnson Taiwan Ltd

    collaborator INDUSTRY

  • Taipei Institute of Pathology

    collaborator OTHER_GOV

  • Taipei City Hospital

    lead OTHER_GOV

Principal Investigators

  • MING-CHYI HUANG, M.D., Ph.D. · Department of Psychiatry, Taipei City Hospital, Songde Branch, Taipei, Taiwan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-05-31
Completion
2012-07-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02075528 on ClinicalTrials.gov