Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,483
- 主要终点
- Efficacy evaluation based on Beck Depression Inventory- Second Edition (BDI-II)
研究概览
简要总结
The objective of this survey was to understand the safety and efficacy of PAXIL tablets ("PAXIL", hereinafter) when it was started at 20 mg/day in subjects with depression or in a depressed state.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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 depression or in a depressed state
- •Patients who start taking paroxetine at 20mg a day
排除标准
- •Patients who have been treated with paroxetine prior to this investigation
- •Patients with hypersensitivity to paroxetine
- •Patients taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
- •Concomitant use in patients taking pimozide
研究组 & 干预措施
Patients prescribed PAXIL
Patients with depression or in a depressed state starting PAXIL at 20 mg/day during study period
干预措施: Paroxetine (Drug)
结局指标
主要结局
Efficacy evaluation based on Beck Depression Inventory- Second Edition (BDI-II)
时间窗: 12 weeks
The investigator asked each subject to fill out the self-administered form of BDI-II at every clinical visit (recommended clinical visit schedule: 1, 2, 4, 8, and 12 weeks after the start of treatment).
Efficacy evaluation based on overall improvement
时间窗: 12 weeks
The investigator compared the general condition over 1 week before each clinical visit with that over 1 week before the start of treatment with PAXIL.
Efficacy evaluation based on severity by symptoms
时间窗: 12 weeks
At every clinical visit, the investigator rated each of the specified symptoms including depressed mood, loss of interests/concerns, anxiety, lack of motivation, physical symptoms, and sleep disorders.
Incidence of adverse events
时间窗: 12 weeks
Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice
次要结局
未报告次要终点