Special Drug Use Investigation for PAXIL Tablet (Pediatric Panic Disorder)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 主要终点
- Incidence of adverse events in Japanese pediatric subjects with panic disorder treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice
研究概览
简要总结
The objectives of this survey was to retrospectively collect and evaluate the information on the efficacy and safety of PAXIL tablets ("PAXIL", hereinafter) in pediatric subjects (aged under 18) with panic disorder under conditions of actual use.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged under 18 at the time of the panic disorder diagnosis
- •Aged under 18 on the starting day of PAXIL treatment
- •Having been making periodic visits to the hospital to receive treatment for panic disorder
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 patients taking pimozide
研究组 & 干预措施
Subjects prescribed PAXIL
Pediatric subjects with panic disorder 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 pediatric subjects with panic disorder treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice
时间窗: From the starting day of the treatment to the time of treatment termination/discontinuation was assessed from 1 month at minimum up to 2 years
Efficacy evaluation based on overall improvement
时间窗: From the starting day of the treatment to the time of treatment termination/discontinuation was assessed from 1 month at minimum up to 2 years
次要结局
未报告次要终点