An Observational Drug Utilization Study of SYCREST^® (Asenapine) in the United Kingdom
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Gender of Asenapine Participants Less Than 18 Years Old Initiating Asenapine During the First Year Since Drug Product Marketing in UK
研究概览
简要总结
This study is designed to describe asenapine prescribing patterns in the United Kingdom (UK) during the post-approval period under conditions of usual practice. The use of asenapine in Bipolar Disorder and other indications will be described. To provide epidemiological and clinical perspective, use of aripiprazole and other comparator drugs will be described.
详细描述
The data source for this study will be the Clinical Practice Research Database (CPRD) in the UK. New users of asenapine during the period following the UK marketing launch of asenapine will be identified in the CPRD. Use in Bipolar Disorder and other indications, as well as baseline demographic and physical characteristics, including prior health status, comorbidities, concomitant medications and healthcare resource utilization, will be described for the asenapine cohort, for participants aged 18 or greater. Use of asenapine in the general practice setting among pediatric participants will be described.
The primary comparison cohort will be aripiprazole. Participants in the aripiprazole cohort will be matched to participants treated with asenapine based on respective time after market entry. In addition, non-matched cohorts will be used to describe utilization of aripiprazole and other comparators.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Aripiprazole
干预措施: Aripiprazole (Drug)
Quetiapine
干预措施: Quetiapine (Drug)
Asenapine
干预措施: Asenapine (Drug)
Risperidone
干预措施: Risperidone (Drug)
Amisulpride
干预措施: Amisulpride (Drug)
Olanzapine
干预措施: Olanzapine (Drug)
Ziprasidone
干预措施: Ziprasidone (Drug)
Iloperidone
干预措施: Iloperidone (Drug)
Paliperidone
干预措施: Paliperidone (Drug)
Lurasidone
干预措施: Lurasidone (Drug)
Clozapine
干预措施: Clozapine (Drug)
Sertindole
干预措施: Sertindole (Drug)
Zotepine
干预措施: Zotepine (Drug)
结局指标
主要结局
Gender of Asenapine Participants Less Than 18 Years Old Initiating Asenapine During the First Year Since Drug Product Marketing in UK
时间窗: Baseline observation period (minimum of at least 365 days prior to date of prescription)
Frequency and Proportion of Use, by Psychiatric Diagnosis, Among Asenapine and Aripiprazole Participants Aged 18 or Greater
时间窗: From baseline through 730 days after date of prescription
Frequency and Proportion of Use Among Asenapine and Aripiprazole Participants Aged 18 or Greater with Schizophrenia and No Diagnosis of Bipolar Disorder
时间窗: From baseline through 730 days after date of prescription
Frequency and Proportion of Use Among Asenapine and Aripiprazole Participants Aged 18 or Greater with No Diagnosis of Bipolar Disorder or Schizophrenia, by Other Diagnosis
时间窗: From baseline through 730 days after date of prescription
Baseline Age of Asenapine Participants Aged 18 or Greater Initiating Asenapine During the First Year Since Drug Product Marketing in UK
时间窗: Baseline observation period (minimum of at least 365 days prior to date of prescription)
Gender of Asenapine Participants Aged 18 or Greater Initiating Asenapine During the First Year Since Drug Product Marketing in UK
时间窗: Baseline observation period (minimum of at least 365 days prior to date of prescription)
Frequency and Proportion of Pediatric Use, by Psychiatric Diagnosis
时间窗: From baseline through 365 days after date of prescription
Baseline Age of Asenapine Participants Less Than 18 Years Old Initiating Asenapine During the First Year Since Drug Product Marketing in UK
时间窗: Baseline observation period (minimum of at least 365 days prior to date of prescription)
次要结局
未报告次要终点