An Observational Post-Authorization Safety Surveillance (PASS) Study of Sycrest® (Asenapine) Among Patients Aged 18 and Older Diagnosed With Bipolar Disorder

Organon and Co0 个研究点目标入组 42 人开始时间: 2013年7月1日最近更新: 2022年2月4日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Organon and Co
入组人数: 42
主要终点: Number of Participants with Bipolar Disorder with Identified and Potential Clinically Important Risks

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study will assess asenapine (Sycrest®) use in participants with bipolar disorder; comparison will be made to the use of risperidone (RISPERDAL®CONSTA®) and olanzapine (Zyprexa®). The occurrence of identified and potential clinically important risks will also be assessed.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Retrospective

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

未提供

排除标准

未提供

结局指标

主要结局

Number of Participants with Bipolar Disorder with Identified and Potential Clinically Important Risks

时间窗: Approximately 1 year

Identified and potential clinically important risks will include: extrapyramidal symptoms, somnolence and sedation, neuroleptic malignant syndrome, rhabdomyolysis, seizure, hyperprolactinaemia, orthostatic hypotension, neutropenia, allergic reactions, dyslipidaemia and diabetes mellitus with the use of asenapine versus risperidone or olanzapine

次要结局

Number of Participants with Schizophrenia with Identified and Potential Clinically Important Risks(Approximately 1 year)
Number of Participants without Diagnoses of Schizophrenia or Bipolar Disorder with Identified and Potential Clinically Important Risks(Approximately 1 year)

研究者

发起方

Organon and Co

申办方类型

Industry

责任方

Sponsor

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