Special Drug Use Investigation for PAXIL Tablet (Long-term)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 339
- 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
This surveillance study is designed to detect adverse events (particularly clinically significant adverse drug reactions) occurring in clinical settings and to examine factors likely to affect the safety and efficacy of paroxetine in long-term use (1 year).
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/depressed state or panic disorder
- •PAXIL must be used for long-term
排除标准
- •Patients who had been taking PAXIL since before the start of the survey
- •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 for long-term use
Patients with depression/depressed state or 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 subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice
时间窗: 1 year
Presence/absence of concomitant use of drugs metabolized by CYP2D6
时间窗: Within 2 weeks after discontinuation or completion of treatment
PAXIL inhibits drug-metabolizing enzyme CYP2D6, and it takes about 1 week following discontinuation of PAXIL for this CYP2D6 function to recover from the inhibiting effect. Since it requires attention if drugs that are metabolized by CYP2D6 are administered during this recovery period, it was decided to investigate the presence/absence of use of drugs metabolized by CYP2D6 within 2 weeks after discontinuation of treatment in patients for whom treatment with PAXIL was discontinued, as well as the safety thereof.
Presence/absence of concomitant use of products containing Saint John's Wort (Hypericum perforatum; "SJW", hereinafter)
时间窗: 1 year
Although the action mechanism for this is not clear, SJW has been reported to have the action of inhibiting reuptake of serotonin, noradrenaline and dopamine, and to exhibit an antidepressant effect. Since PAXIL also acts to inhibit serotonin reuptake, concomitant use of products containing SJW is thought to have an effect upon the serotonin reuptake inhibiting action of PAXIL, so it was decided to check for concomitant use of products containing SJW and investigate the safety of such concomitant use.
次要结局
未报告次要终点