NCT03386851已完成不适用
Post-Marketing Surveillance of Safety and Effectiveness of Abilify Maintena® Injections in Korean Patients With Schizophrenia or Bipolar 1 Disorder Under the "New Drug Re-Examination"
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,030
- 试验地点
- 1
- 主要终点
- The incidence rate and the number of Adverse Events (AE)/ Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR
研究概览
简要总结
This is a Post-Marketing Surveillance (PMS) of Abilify Maintena® Injections in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: Ministry of Food and Drug Safety(MFDS) Notification).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with schizophrenia or bipolar 1 disorder
- •Patients who are prescribed Abilify Maintena® Injections treatment as per investigator's medical judgment
- •Patients giving written authorization to use their personal and health data and starting Abilify Maintena® Injections treatment after agreement is in place and investigators provide the explanation about objective and feature of the surveillance
排除标准
- •Patients with known hypersensitivity to Aripiprazole or any excipients of Abilify Maintena® Injections
- •Elderly patients with dementia related psychosis
- •Patients who have been treated with Abilify Maintena® Injections
- •Patients with score 0(Not assessed) or 1(Normal, not at all ill) in the Clinical Global Impression-Severity(CGI-S)
- •Patients participating in other clinical trial
- •All patients who in medical judgment of the investigator would not be appropriate for inclusion criteria in the surveillance
结局指标
主要结局
The incidence rate and the number of Adverse Events (AE)/ Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR
时间窗: until 28 days after discontinuation
次要结局
- Mean change from baseline to last visit inPersonal and Social Performance Scale (PSP) score.(at least 12, 24 weeks interval from baseline)
- Mean change from baseline to last visit in Clinical Global Impression - Severity of Illness scale (CGI-S) score.(at least 12, 24 weeks interval from baseline)
- Overall judgement at last visit compared to baseline, judged holistically according to clinical symptoms: "Effective", "No effect", "Worsen"(at least 12, 24 weeks interval from baseline)
- Clinical Global Impression - Improvement scale (CGI-I) score at the last visit(at least 12, 24 weeks interval from baseline)
研究者
研究点 (1)
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