NCT00955604已完成不适用
Investigation of the Occurrence of Serotonin Toxicity in Parkinson's Disease (PD) Patients Treated Concomitantly With Rasagiline and Antidepressants, Using Retrospective Chart Review
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,500
- 主要终点
- The frequency of serotonin toxicity, as determined by the Adjudication Committee will be calculated for each Group. The primary comparison will be Group R+AD vs. Group R and vs. Group AD
研究概览
简要总结
To identify the occurrence of serotonin toxicity in Parkinson's Disease (PD) patients receiving antidepressant therapy and rasagiline, compared to those receiving rasagiline without antidepressant medications and compared to PD patients receiving antidepressants, but not rasagiline.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with a diagnosis of PD
- •Rasagiline treatment as mono- or adjunct therapy for PD with concomitant antidepressant medication (SSRIs, SNRIs, St. John's wort and/or TCAs) at any time during the specified review period, OR Rasagiline treatment as mono- or adjunct therapy for PD without concomitant antidepressant medication (SSRIs, SNRIs, St. John's wort and/or TCAs) at any time during the specified review period. OR Antidepressant therapy (SSRIs, SNRIs, St. John's wort and/or TCAs) and any other dopaminergic anti-PD treatment besides rasagiline or selegiline at any time during the specified review period
- •Willing to consent to review of office chart and to review of records of ER visits and/or hospitalizations corresponding to the review window, if required
- •Patients previously participating in a rasagiline clinical trial (and their follow-up protocols) are eligible, provided that they did not receive antidepressant therapy during trial participation.
- •In addition to the above criteria, each group has specific inclusion criteria stated below:
- •Group R+AD: Enrollment in this group requires that patients must have taken rasagiline and an antidepressant (SSRIs, SNRIs, St. John's wort and/or TCAs, regardless of indication) within 14 days of each other (or five weeks, if fluoxetine preceded rasagiline).
- •Group R: Enrollment in this group requires patients must have at least 2 months of rasagiline use.
- •Group AD: Patients must be taking an approved dopaminergic medication for PD. Enrollment in this group requires that patients must have at least 2 months of treatment with an antidepressant medication.
排除标准
- •Use of rasagiline for any indication other than PD
- •Patients taking a monoamine oxidase inhibitor (MAOI) antidepressant and/or selegiline
- •Inability or unwillingness to request records of ER visits and/or hospitalizations corresponding to the review period.
研究组 & 干预措施
Group R
At least 2 months of rasagiline
干预措施: Group R Rasagiline (Drug)
Group AD
At least 2 months of Anti-PD and Rasagiline
干预措施: Group AD Anti-PD + Antidepressant (Drug)
Group R+AD
Group R+AD Rasagiline and an antidepressant (SRIs, SNRIs, St. John's wort and/or TCAs) for at least 14 days
干预措施: Group R+AD Rasagiline + Antidepressant (Drug)
结局指标
主要结局
The frequency of serotonin toxicity, as determined by the Adjudication Committee will be calculated for each Group. The primary comparison will be Group R+AD vs. Group R and vs. Group AD
时间窗: 9 months
次要结局
未报告次要终点
研究者
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