Drug Use-results Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 369
- 试验地点
- 47
- 主要终点
- Safety assessed by vital signs: Blood pressure (sitting)
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of quetiapine in actual clinical settings.
详细描述
This is a post-marketing use-result survey study required for products in Japan. The investigator will register the patient who have been taking this product for the first time within 14 days after the start of treatment (inclusive of the start day). For each of the registered patients (including withdrawals and dropouts), the investigator will enter the survey data on the case report form.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with depressive symptoms of bipolar disorder
- •Patients who have previously not been treated with quetiapine fumarate (immediate-release formulations of quetiapine fumarate and Bipresso Extended-Release Tablets)
排除标准
- 未提供
研究组 & 干预措施
Patients with depression in bipolar disorder
Patients with depression in bipolar disorder who are treated with quetiapine extended-release tablets for the first time
干预措施: Quetiapine (Drug)
结局指标
主要结局
Safety assessed by vital signs: Blood pressure (sitting)
时间窗: Up to Week 12
To assess blood pressure as a criteria of safety variables
Safety assessed by vital signs: Pulse rate (sitting)
时间窗: Up to Week 12
To assess pulse rate as a criteria of safety variables
Safety assessed by body weight
时间窗: Up to Week 12
To assess body weight as a criteria of safety variables
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: Baseline and up to Week 12
To assess MADRS as a criteria of efficacy variables
Safety assessed by incidence of serious adverse events
时间窗: Up to Week 12
To assess incidence of serious adverse events as a criteria of safety variables.
Safety assessed by incidence of adverse drug reactions
时间窗: Up to Week 12
To assess incidence of adverse drug reactions as a criteria of safety variables.
Safety assessed by laboratory values and changes from baseline over time
时间窗: Up to Week 12
To assess profile of laboratory value transition and potential clinical significance as a criteria of safety variables. The investigators will assess the severity and clinical relevance, and will report as an adverse event as necessary.
Safety assessed by 12-lead electrocardiogram
时间窗: Up to Week 12
To assess 12-lead electrocardiogram as a criteria of safety variables
Change from baseline in Clinical Global Impression-Bipolar-Severity of illness (CGI-BP-S)
时间窗: Baseline and up to Week 12
To assess CGI-BP-S as a criteria of efficacy variables
Efficacy assessed by Clinical Global Impression-Bipolar-Change (CGI-BP-C)
时间窗: Up to Week 12
To assess CGI-BP-C as a criteria of efficacy variables
次要结局
未报告次要终点