Serotonin Effect in Non-Ulcer Dyspepsia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- Upper gastrointestinal symptom absence after 6 weeks treatment.
研究概览
简要总结
The purpose of this study is to investigate whether Efexor (venlafaxine) is effective in the treatment of functional dyspepsia.
详细描述
BACKGROUND: A good 60% of patients presenting with upper abdominal complaints have functional dyspepsia. Usually, acid-suppressive drugs are given as first-line therapy for upper gastrointestinal symptoms. However, results are often not satisfying and symptoms persist. Since many patients with functional gastrointestinal diseases are more anxious and depressed in comparison to healthy controls, several studies investigated the use of antidepressant agents in these patients. Although many studies were underpowered, promising results were obtained with tricyclic antidepressant and mianserin in patients with irritable bowel syndrome. There is still a need for a placebo controlled study with antidepressants in patients with functional dyspepsia.
OBJECTIVE: To investigate the effectiveness of venlafaxine, a selective serotonin and norepinephrine reuptake inhibitor, for treatment of patients with functional dyspepsia.
STUDY DESIGN: A randomized, double blind, placebo controlled trial.
STUDY POPULATION: Consecutive patients with persistent upper GI symptoms without abnormalities at upper gastrointestinal endoscopy.
PRIMARY ENDPOINTS: Upper gastrointestinal symptom absence after 6 weeks treatment.
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
- •Persistent upper gastrointestinal symptoms;
- •Absence of any serious organic cause of the complaints at previous upper gastrointestinal endoscopy (including gastric ulcer, carcinoma, oesophageal reflux disease, portal hypertension, hernia hiatus >2 cm or severe gastritis);
- •Over 18 years of age;
- •Written informed consent.
排除标准
- •History of bipolar disorder;
- •Contra-indication for venlafaxine;
- •Current or planned pregnancy or lactation;
- •Diagnosed alcoholism, anorexia nervosa or bulimia;
- •Current or recent (within the last two weeks) use of a selective serotonin re-uptake inhibitor (SSRI) or MAO-inhibitor;
- •Any other condition or circumstance that, in the opinion of the investigator or the physician, would compromise the subject's successful participation in this trial.
结局指标
主要结局
Upper gastrointestinal symptom absence after 6 weeks treatment.
次要结局
- Anxiety and depression after venlafaxine treatment
- Health related quality of life after venlafaxine treatment
- The association between serotonin transporter protein and 5-HT receptor polymorphisms and efficacy of venlafaxine.