Associations Between Gene-Polymorphisms, Endo-Phenotypes for Depression and Antidepressive Treatment (AGENDA)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes in the response on the combined dexamethasone corticotropin-releasing hormone test before and after 4 weeks treatment with escitalopram or placebo.
研究概览
简要总结
The purpose of this study is to determine whether outcome following antidepressant treatment can be used as a tool to evaluate endo-phenotypes for depression.
详细描述
The research in depression has for some years focused at the identification of endo-phenotypes. Endo-phenotypes are heritable biological or psychological markers, which are more commonly found in patients and their healthy relatives than in the general population.
Recent studies point at disturbed regulation of the hypothalamic-pituitary-adrenocortical (HPA) system as a possible endo-phenotype for depression.
The hypothesis of AGENDA are that endo-phenotypes are affected by treatment with antidepressants in healthy first degree relatives.
AGENDA is a four week randomized, placebo-controlled, double-blind trial in which first degree relatives of patients with the diagnosis of depression are randomised in to two groups, which are treated with either placebo or antidepressant medicine (Cipralex). We expect to include 80 healthy subjects, with the predisposition for depression, since one of their parents or siblings recently was treated for depression.
The subjects will be examined before and after four weeks of treatment by a thorough interview concerning psychiatric symptoms (SCAN), including depressive symptoms, personality, perceived stress and cognitive function. The effect of antidepressant on stress is measured with saliva-cortisol and by the response to the combined dexamethasone corticotropin-releasing (CRH) hormone test. Additionally, MR and PET scans of the 5-HT4 receptor function will be conducted before and after 4 weeks of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Offsprings or siblings of patients with major depression
- •Born in Denmark with European parents and grandparents
- •For women; not pregnant or breastfeeding
- •Written informed consent
排除标准
- •Somatically illness or other handicaps which make participation in the study impossible
- •Daily intake of drugs interfering with corticosteroids or escitalopram
- •Hypersensitivity to escitalopram, dexamethasone or human corticotropin-releasing hormone
- •Former medical or psychological treatment for diseases in the affective or schizophrenic spectrum
- •Ongoing addiction of alcohol or psychoactive drugs
研究组 & 干预措施
A Escitalopram 10 mg
Escitalopram 10 mg
干预措施: Escitalopram (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in the response on the combined dexamethasone corticotropin-releasing hormone test before and after 4 weeks treatment with escitalopram or placebo.
时间窗: 4-6 weeks
次要结局
- Changes in scores before and after 4 weeks treatment with escitalopram or placebo on: Cognition(4-6 weeks)
- Social function(4-6 weeks)
- Neuroticism(4-6 weeks)
- Subjective; sleep, pain, aggression, depression, anxiety, quality of life, perceived stress and side-effects(4-6 weeks)
- Receptor status by PET-scans(4-6 weeks)
- Inflammatory parameters(4-6 weeks)
- Paraclinical measures(4-6 weeks)
- MR and fMRI(4-6 weeks)