NCT01614041已完成4 期
Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder: a Multi-center, Randomized, Usual Dose-controlled Trial
Sumitomo Pharma (Suzhou) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 274 人开始时间: 2012年1月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- Percentage of patients whose Hamilton Anxiety Scale (HAMA) score change downwards ≥ 50% from baseline to 6 weeks treatment
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of comparative high dose Tandospirone Citrate in the treatment of patients with generalized anxiety disorder.
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
- None
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
- •18-65 years old
- •Male or female
- •Diagnosed with GAD according to DSM-IV
- •HAMA score≥17
- •Provide with written informed consent
- •Agree to be washed-out for two weeks if receiving SSRI, SNRI or NASA.
排除标准
- •Serious suicidal tendency
- •The score of the sixth item of HAMA ≥3
- •The score of HAMD ≥21
- •Pregnant or lactating women
- •History of allergic or hypersensitivity to tandospirone
- •Serious or unstable cardiac, renal, neurologic, cerebrovascular, metabolic, or pulmonary disease
- •Secondary anxiety disorders
- •Drug or alcohol dependence within 1 year
- •Patients currently taking benzodiazepine drugs
- •Drivers and dangerous machine operators
- •Participated in other clinical studies in the last 30 days
- •Patients with clinically significant ECG or laboratory abnormalities
- •Patients with a history of epilepsy
- •Patients with abnormal TSH concentration
研究组 & 干预措施
Study Group
Experimental
Comparative high dose of tandospirone treatment, 60 mg/day
干预措施: Comparative high dose of tandospirone treatment (Drug)
Control Group
Active Comparator
Patient randomized to control group is administrated with usual dose of tandospirone treatment, 30 mg/day
干预措施: Usual dose treatment of Tandospirone (Drug)
结局指标
主要结局
Percentage of patients whose Hamilton Anxiety Scale (HAMA) score change downwards ≥ 50% from baseline to 6 weeks treatment
时间窗: 6 weeks
HAMA score changes downwards ≥ 50% indicate significant improvement; HAMA score changes downwards ≥ 75% indicate remission
次要结局
- HAMA factor score changes after treatment(6 weeks)
- HAMA score changes from baseline to 6 weeks treatment(6 weeks)
- Percentage of patients whose HAMA score ≤ 7 after 6 weeks treatment(6 weeks)
研究者
研究点 (1)
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