Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 390
- 主要终点
- Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice
研究概览
简要总结
Overall improvement, severities and changes of specific clinical symptoms were surveyed in outpatients with depression or in a depressed state to evaluate the efficacy and safety of PAXIL tablets in patients in whom the PAXIL dose was increased and those treated with a constant dose.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Subjects who is 18 years or more
- •Subjects diagnosed with depression or in a depressed state
排除标准
- •Subjects who have been treated with paroxetine prior to this investigation
- •Subjects with hypersensitivity to paroxetine
- •Subjects taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
- •Concomitant use in subjects taking pimozide
研究组 & 干预措施
Patients prescribed PAXIL
Patients with depression or depressed state prescribed PAXIL during study period
干预措施: Paroxetine (Drug)
结局指标
主要结局
Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice
时间窗: 12 weeks
Efficacy evaluation based on Beck Depression Inventory - Second Edition (BDI-II)
时间窗: 12 weeks
The investigator asked the patient to fill out a set of self-administered BDI-II forms at each time of the patient's visits to the medical center (Patients were to make visits around 1, 2, 4, 8 and 12 weeks after starting PAXIL).
Efficacy evaluation based on overall improvement
时间窗: 12 weeks
The investigator comprehensively assessed the general condition of the patient at each time of the patient's visits to the medical center and rated the condition on a seven-grade eight-category scale (7 grades of markedly improved, moderately improved, slightly improved, unchanged, slightly worsened, worsened and severely worsened; a category of unassessable).
Efficacy evaluation based on severities of specific symptoms
时间窗: 12 weeks
The investigator rated the severities of depressed mood, anxiety, feeling irritated, hypobulia, physical symptoms and sleep disorder on a four-grade scale (none, mild, moderate and severe) based on the interview and the results of BDI-II at each time of the patient's visits to the medical center (patients were to make visits around 1, 2, 4, 8 and 12 weeks after starting PAXIL).
次要结局
未报告次要终点