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临床试验/NCT00697658
NCT00697658已完成不适用

INVega Is Studied In an Observational Design in the Netherlands

Janssen-Cilag B.V.0 个研究点目标入组 27 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
27
主要终点
Change from baseline in CGI-S score at the end of the study

研究概览

简要总结

The purpose of this study is to explore efficacy, tolerability and safety of paliperidone Extended Release (ER) in 250 schizophrenia patients who started treatment with paliperidone ER in a naturalistic setting.

详细描述

This is an observational, prospective, multicenter 6-month study to explore efficacy, tolerability and safety of paliperidone Extended Release (ER) in 250 schizophrenia patients who started treatment with paliperidone ER in a naturalistic setting. The primary objective is to explore changes in Clinical Global Impression of Severity (CGI-S) score from baseline up to 26 weeks, in subgroups of schizophrenia patients who started treatment with paliperidone ER. Secondary objectives are: 1) To explore changes in mental health and social functioning based on routine outcome assessments in the Netherlands, the Health of the Nation Outcome Scales (HoNOS) and Global Assessment of Functioning (GAF), in schizophrenia patients who started treatment with paliperidone ER ; 2) To explore changes in patient's satisfaction with treatment, changes in number of ambulant contacts, changes in body weight, changes in concomitant therapy and to explore adverse events in schizophrenia patients who started treatment with paliperidone ER; and to explore possible association between CGI-S, GAF and HoNOS.

The patients will receive paliperidone ER (6 mg, 9 mg or other dosages as directed on the label) once daily for the period of 6 month. Which dosage of paliperidone ER the patients receive will be at the discretion of the investigator and according the Summary of Product Characteristics (SmPC). Because the study is observational, dosage, administration and duration of treatment is at discretion of treating physician.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient meets the DSM-IV criteria for schizophrenia
  • Switched to or started on paliperidone ER, not longer than two weeks ago
  • In 24 hours before initiation of paliperidone ER treatment, CGI-S, patient satisfaction with treatment, concomitant therapy, body weight, GAF and HoNOS data are available
  • Patient or legal representative has signed the informed consent form within two weeks after starting treatment with paliperidone ER

排除标准

  • No use of paliperidone ER, clozapine, any conventional depot neuroleptic or long acting atypical antipsychotic drugs during 3 months before starting paliperidone ER
  • No participation in an investigational drug trial in 30 days prior to starting paliperidone ER
  • No history of neuroleptic malignant syndrome
  • No known hypersensitivity to paliperidone ER or risperidone
  • No patients hospitalized for a period longer than 12 weeks

研究组 & 干预措施

001

干预措施: Paliperidone ER (Drug)

结局指标

主要结局

Change from baseline in CGI-S score at the end of the study

时间窗: Week 26 or drop out visit

次要结局

  • Change in GAF score(Week 26 or drop out visit)
  • Patient satisfaction with treatment(Week 26 or drop out visit)
  • Change in Health of the Nation Outcome Scales (HoNOS)(Week 26 or drop out visit)

研究者

申办方类型
Industry
责任方
Sponsor

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