Effect of Escitalopram vs. Reboxetine on Somatic and Visceral Sensitivity of Patients With Major Depressive Disorder: a Randomized, Double Blind Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- rectal distension Transcutaneous Electrical Neuro-Stimulation
研究概览
简要总结
Patients with major depressive disorder (MDD) commonly have many gastrointestinal complaints. Gastrointestinal pain is classified into 2 categories: visceral and somatic pain. The main aim of this study is to compare somatic and visceral sensitivity between healthy people and pateints with MDD. These two sensitivities will be assessed by the 2 following tests: standardized rectal distension and Transdermal transcutaneous electric nerve stimulation. Thereafter, patients with MDD will be randomly allocated to escitalopram or reboxetine. After 6 weeks of treatment, somatic and visceral sensitivity will be reassessed.
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
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •MDD according with DSM-IV-TR
- •Hamilton depression scale > 21
排除标准
- •history of gastrointestinal illness
- •history of escitalopram, citalopram or reboxetine allergy.
- •history of escitalopram, citalopram or reboxetine resistant depression.
- •other axis I psychiatric disorder.
- •a punctuation > 2 on the suicide item of the Ham-D.
- •history of ECT during the past 6 months.
- •pharmacological failure of the present depressive episode.
- •pregnancy or nursing.
- •treatment with drugs that may interact with study medication.
研究组 & 干预措施
1
subjects with MDD randomized to Escitalopram
干预措施: escitalopram (Drug)
2
MDD patients receiving reboxetine
干预措施: Reboxetine (Drug)
3
Healthy volonteers
干预措施: No intervention (Other)
结局指标
主要结局
rectal distension Transcutaneous Electrical Neuro-Stimulation
时间窗: 1-7 weeks
次要结局
未报告次要终点