NCT00226642Unknown4 期
Behandlung Von Leichten Und Unterschwelligen Depressionen. Eine Randomisierte, Kontrollierte Studie Zum Wirksamkeitsnachweis Eines Serotonin-Wiederaufnahme-Hemmers (SSRI), Einer Kognitiven Verhaltenstherapie Und Einer Freien Therapiewahl ("Treatment of Mild and Subthreshold Depressive Disorders". A Randomized, Controlled Trial on the Efficacy of a Serotonin-Reuptake-Inhibitor (SSRI), a Cognitive-Behavioral Therapy and of Free Choice Between SSRI and CBT")
适应症
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 369
- 试验地点
- 1
- 主要终点
- HAMD (changes between baseline and individual endpoint)
研究概览
简要总结
The purpose of this study is to determine the efficacy of a SSRI, cognitive-bahavioral-therapy and a free choice between SSRI and CBT in a sample of primary care patients suffering from mild to moderate depression.
Hypotheses:
- SSRI is superior to placebo
- CBT is superior to a non-specific supporting group therapy
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subthreshold and mild depressive disorders including dysthymia (HAMD: 8-22)
- •informed consent
排除标准
- •severe mood disorders
- •bipolar disorder
- •recurrent brief depression
- •suicidality
- •alcohol or drug dependency
- •obsessive-compulsive disorder
- •schizoaffective disorder / schizophrenia
- •pregnancy
结局指标
主要结局
HAMD (changes between baseline and individual endpoint)
IDS (changes between baseline and individual endpoint)
次要结局
- CGI (changes between baseline and individual endpoint)
- BDI (changes between baseline and individual endpoint)
研究者
研究点 (1)
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