NCT01524497已完成2 期
A Clinical Study on Efficacy And Safety of Trazodone Hydrochloride Prolonged-Release Tablets for Treatment of Depression A Multicenter, Randomized, Double-Blind, Parallel Controlled Study
Lee's Pharmaceutical Limited1 个研究点 分布在 1 个国家目标入组 382 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 382
- 试验地点
- 1
- 主要终点
- Change in Hamilton Depression Rating Scale-17 score
研究概览
简要总结
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of trazodone hydrochloride prolonged-release tablets for treatment of depression in Chinese population.
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 (Investigator, Outcomes Assessor)
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
- •Age between 18 and 65, males and females, outpatients or inpatients;
- •Single episode or recurrent depression according to DSM-IV (Version 4) criteria;
- •Scores > 18 on 17-item HAM-D at screening and baseline visits with a decrease not exceeding 20% between the two visits;
- •Symptoms of depression for at least 1 month;
- •Patients or their dependents/guardians providing signed informed consent forms.
排除标准
- •Serious suicide attempts (≥ 3 on item 3 'Suicide' of HAMD);
- •Depressive episode, with psychotic symptoms;
- •Refractory depression;
- •Depressive episode secondary to other mental or physical disorders;
- •Bipolar disorder;
- •Significant reduction in body weight and malnutrition induced by major depression;
- •Serious or unstable heart, hepatic, renal, endocrine and hematologic disease or malignant tumors;
研究组 & 干预措施
Trazodone
Active Comparator
干预措施: Trazodone (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Hamilton Depression Rating Scale-17 score
时间窗: six weeks
17-item Hamilton Depression Rating scale were evaluated at the basemline and six weeks after treatment, the changes were recorded and used as primary outcome measurement.
次要结局
- Changes in HAMA-14 score(Six weeks)
- CGI-Severity of illness and CGI-Global improvement(Six weeks)
- Rate changes of responders/patients(Six weeks)
- Changes in evaluation of sleep quality and sexual dysfunction(Six weeks)
研究者
研究点 (1)
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