NCT00049972已完成4 期
An Open Label Study Assessing Paxil CR (Paroxetine CR) in Patients With Major Depressive Disorder Who Discontinued Treatment With Selective Serotonin Reuptake Inhibitors or a Selective Serotonin/Norepinephrine Reuptake Inhibitor Due to Intolerability
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 646
- 试验地点
- 71
- 主要终点
- The proportion of patients who prematurely terminated treatment due to treatment emergent adverse events
研究概览
简要总结
A study to obtain safety and tolerability data
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient must have primary diagnosis of Major Depressive Disorder (MDD).
- •Discontinued a selective serotonin reuptake inhibitor (SSRI)or serotonin-norepinephrine reuptake inhibitor (SNRI) regimen due to intolerability.
- •Minimum time frame between last dose of previous antidepressant and initiation of study drug is one week.
- •Maximum time frame between last dose of prior antidepressant and initiation of study drug is 2 months.
排除标准
- •Patient has previously been treated with the study drug.
- •Is experiencing an adverse event attributed to previous SSRI/SNRI use that has not been resolved at least one week prior to Baseline Visit.
- •Has a history of seizure disorder.
- •Has met criteria for substance abuse or dependence within 6 months prior to Baseline Visit.
- •Currently using an antidepressant.
- •Currently pregnant.
结局指标
主要结局
The proportion of patients who prematurely terminated treatment due to treatment emergent adverse events
次要结局
- Recurrence rates of adverse events causing intolerability of previous SSRI/SNRI, Adverse event incidence rates, Mean change from baseline in the Beck Depression Inventory-II total score, Proportion of responsers based on teh CGI Global Improvement Item
研究者
研究点 (71)
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