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临床试验/NCT01968161
NCT01968161Unknown4 期

An Open-label Switch Study to Asenapine in the Early Stage of Psychosis

Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
12
试验地点
1
主要终点
Impact of switching to asenapine

研究概览

简要总结

We propose a use of a unique facility, the databank at the CNDV, to examine the impact of switching subjects to asenapine in an open-label naturalistic setting. This offers the following advantages: i) providing data on a particularly important population, i.e., subjects who are at the inception of treatment for a psychotic disorder and who are likely to remain on a given drug on a long-term basis; ii) its inclusion in a rich clinical setting, with a clinical team dedicated to provide innovative interventions; iii) its naturalistic design, that will allow to obtain data that will be applicable to "real-life" clinical settings; indeed, subjects who will be switched to asenapine within the current project are those we would switch to this drug in our daily practice.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Meeting DSM-IV criteria for schizophrenia (SZ) or related SZ spectrum psychotic disorders
  • having provided a consent to include data on our databank,and being able to provide informed consent
  • willingness to participate to the assessments
  • being over 18 years of age
  • being in a clinical situation that warrants switch to asenapine

排除标准

  • suffering from a primary drug-induced psychosis
  • being at significant risk for suicide or assault
  • unstable medical condition
  • persistence of psychotic symptoms despite adequate treatment to an extent that clozapine would be required
  • being treated with antipsychotic for 5 years or more
  • having contraindications(allergy to asenapine)
  • being pregnant or lactating

研究组 & 干预措施

Asenapine

Other

Open label switch to asenapine: asenapine will be introduced at the target dose (5 mg bid)

干预措施: Asenapine (Drug)

结局指标

主要结局

Impact of switching to asenapine

时间窗: 3 months

次要结局

  • Predictors of successful switch to asenapine(3 months)

研究者

发起方
Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
申办方类型
Other
责任方
Sponsor

研究点 (1)

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