NCT00368303已完成3 期
A Multicentre, Double-blind, Active Controlled Trial to Evaluate the Clinical Effects of Immediate Release Paroxetine and Controlled Release Paroxetine in the Treatment of Major Depression
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 362
- 试验地点
- 12
- 主要终点
- Scores on depression rating scale at treatment week 1,2,3,4,6 and 8.
研究概览
简要总结
The study is to investigate the non-inferior efficacy of Paroxetine Controlled Release to Paroxetine Immediate Release, as well as the drug tolerability profile when treated on patients with Major Depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Major Depressive Disorder,score on depression rating scale reach a specific point(17 item Hamilton Depression Scale>18).
排除标准
- •patients use monoamine oxidase inhibitors (MAOIs), benzodiazepines, Chinese herbal medicines, acupuncture, moxibustion or other psychoactive medications other than zolpidem, zopiclone;diagnosed with other Axis I disorder other; not responsive to paroxetine therapy before; pregnant or lactating, have serious medical disorder or condition that would preclude the administration of paroxetine; have a history of seizure disorders (except for febrile seizures in childhood); require treatment with warfarin anticoagulants, phenytoin, cimetidine, sumatriptan, type 1C antiarrhythmics, quinidine or sulfonylurea derivatives; are substance abuse or dependence (alcohol or drugs) within 6 months prior to this trial; have had electroconvulsive therapy within 2 months of entry into the study; pose a current, serious suicidal or homicidal risk; have taken other psychotropic drugs or antidepressants other than MAO inhibitors within 7 days of baseline and MAO inhibitors within 14 days of baseline; have taken any investigational drug, or participated in a clinical trial within the past 3 months; are hypersensitivity to paroxetine; have undergoing formal psychotherapy/psychoanalysis.
结局指标
主要结局
Scores on depression rating scale at treatment week 1,2,3,4,6 and 8.
次要结局
- Scores on clinical impression severity and improvement items at treatment week 1, 2,3,4,6,8
研究者
研究点 (12)
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