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