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临床试验/NCT01685931
NCT01685931已完成4 期

Effectiveness, Safety and Tolerability of Flexibly Dosed Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics and With Acute Symptom of Schizophrenia: A 13-Week, Open-label, Single-arm, Multicenter, Prospective, Interventional Study Followed by a Naturalistic Additional 1 Year Follow up

Xian-Janssen Pharmaceutical Ltd.0 个研究点目标入组 617 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
617
主要终点
The percentage of patients with a 30% reduction from baseline in Positive and Negative Syndrome Scale (PANSS)

研究概览

简要总结

The purpose of this study is to assess the effectiveness, safety and tolerability of flexibly dosed paliperidone palmitate in patients with schizophrenia previously unsuccessfully treated by oral antipsychotics and with acute symptom of schizophrenia.

详细描述

This is a 13-week, open-label (all people know the identity of the intervention), single-arm (one group of patients), multicenter, prospective, interventional study in Chinese patients. In a prospective, interventional study, the patients identified receive a treatment during the course of the research study and are followed forward in time for the outcome of the study. In China, there is still insufficient information about effectiveness, tolerability, and dosage strategy for directly switching from previous oral antipsychotics (drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders) in patients with acute symptoms. Acute symptoms are quick and severe form of illness in its early stage. In addition, there is also lack of information about bridging acute phase to long-term treatment. In this study, patients with multiple types of acute schizophrenia will be recruited and will receive Sustenna (paliperidone palmitate) treatments for 13 weeks. After the acute treatment, the patients will continue to receive the prescribed medication and will be followed up for an additional 52 weeks to assess the outcomes related to long-term treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Previous diagnosis of schizophrenia
  • Experiencing an acute episode, with a Positive and Negative Syndrome Scale (PANSS) total score between 70 and 120, inclusive
  • Patients currently treated with antipsychotic are allowed to be recruited
  • Be medically stable on the basis of clinical laboratory tests performed at screening

排除标准

  • A primary diagnosis other than schizophrenia
  • History of risperidone or paliperidone resistance as defined by failure to respond to 2 adequate treatment periods
  • Clozapine use for treatment refractory schizophrenia
  • Relevant history or current presence of any significant or unstable condition, disease or illness that could limit the participation in the study according to the investigator
  • Woman who is pregnant, breast-feeding, or is planning to become pregnant within 6 months

研究组 & 干预措施

Paliperidone Palmitate

Experimental

干预措施: Paliperidone Palmitate (Drug)

结局指标

主要结局

The percentage of patients with a 30% reduction from baseline in Positive and Negative Syndrome Scale (PANSS)

时间窗: Baseline, Week 13

The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.

次要结局

  • The change from baseline in Clinical Global Impression - Severity (CGI-S)(Baseline, Week 13)
  • The change from baseline in Positive and Negative Syndrome Scale (PANSS) score(Baseline, Week 13)
  • The change from baseline in Medication Satisfaction Questionnaire (MSQ)(Baseline, Week 13)
  • The change from baseline in Involvement Evaluation Questionnaire (IEQ)(Baseline, Week 13)
  • The change from baseline in Medication Adherence Rating Scale (MARS)(Baseline, Week 13)
  • The change from baseline in Medication Preference Questionnaire (MPQ)(Baseline, Week 13)

研究者

发起方
Xian-Janssen Pharmaceutical Ltd.
申办方类型
Industry
责任方
Sponsor

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