NCT00253266已完成4 期
Comparison of Venlafaxine Augmentation With Quetiapine v.s. Placebo in Treatment Resistant Depression
Max-Planck-Institute of Psychiatry1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2008年4月最近更新:
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
- 126
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale (HDRS)
研究概览
简要总结
This is an assessment of the efficacy of venlafaxine-HCL augmentation with the neuroleptic quetiapine in treatment resistant depression.
详细描述
We examine the efficacy of Venlafaxine-HCL augmentation with the neuroleptic Quetiapine in treatment resistant depression in a double-blind randomized clinical trial. Secondary objective is the evaluation of pharmacogenetic factors contributing to drug efficacy in treatment resistant 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male inpatients with a major depressive disorder without psychotic features or with a depressive episode within a bipolar I or II disorder without psychotic features
- •Ages between 20 and 70 years
- •Total score greater than 18 on the Hamilton Depression Rating Scale
- •Documentation of at least one ineffective antidepressant drug trial under adequate dosage for at least 6 weeks in the current episode
排除标准
- •Other psychiatric axis I disorders than those mentioned as Inclusion criteria
- •Acute suicidality (Item 3 of the Hamilton Depression Rating Scale greater than 2)
- •Drug or alcohol addiction
- •Patients with severe hepatic, cardiovascular, neurologic, metabolic or malignant disorders
- •Documentation or report of a previous ineffective treatment trial with venlafaxine, lamotrigine or quetiapine
- •Functional kidney disorders
- •Untreated hypertension
- •Acute treatment with thyroid hormone (less than 3 months)
- •Pregnant or nursing patients
- •Women of childbearing age without effective contraception
研究组 & 干预措施
Verum
Experimental
Quetiapine augmentation
干预措施: Venlafaxine (Drug)
Verum
Experimental
Quetiapine augmentation
干预措施: Quetiapine (Drug)
Placebo
Placebo Comparator
"Placebo" augmentation
干预措施: Venlafaxine (Drug)
结局指标
主要结局
Hamilton Depression Rating Scale (HDRS)
时间窗: after monotherapy and after augmentation
次要结局
- Cognitive function(after monotherapy and after augmentation)
- Self reported psychopathology (Beck Depression Inventory [BDI], State-Trait Anxiety Inventory [STAI])(after monotherapy and after augmentation)
研究者
研究点 (1)
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