NCT01049347已完成3 期
Hypothalamus-pituitary-adrenal System: Role of the Mineralocorticoid Receptor and Longitudinal Study in Depressed Patients
Central Institute of Mental Health, Mannheim1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 1997年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale (21-item version)
研究概览
简要总结
Activation of the hypothalamus-pituitary-adrenal system is monitored using saliva cortisol sampling during the antidepressant treatment with amitriptyline and paroxetine in moderately to severely depressed patients. Additionally, serum and plasma are sampled during the 5-week study period in order to study endocrine and metabolic parameters.
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
- Triple (Participant, Care Provider, Investigator)
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
- •age: above 18
- •depression according DSM-IV
排除标准
- •bipolar disorder
- •substance dependency
研究组 & 干预措施
amitriptyline
Active Comparator
干预措施: amitriptyline (Drug)
paroxetine
Active Comparator
干预措施: paroxetine (Drug)
结局指标
主要结局
Hamilton Depression Rating Scale (21-item version)
时间窗: baseline, weekly assessments for 5 weeks
次要结局
- cortisol in saliva (8.00, 16.00, 22.00) during wash-out (6 days) and 35 days of treatment(daily during wash-out (days -6 to -1) and active treatment (days 1 to 35))
研究者
研究点 (1)
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