Effect of Citalopram on Chest Pain in Patients With Functional Chest Pain
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Global assessment of patient reported change in chest pain after 6 weeks of treatment.
研究概览
简要总结
Non-cardiac chest pain (NCCP) in the absence of musculoskeletal abnormalities, major esophageal motor disorders, gastroesophageal reflux or eosinophilic esophagitis is called functional chest pain (FCP). Most likely multiple factors play a role, such as esophageal hypersensitivity and enhanced perception. Citalopram and other antidepressants are proven to be effective in the treatment of functional gastrointestinal disorders such as irritable bowel syndrome. With this trial the investigators want to assess the effect of citalopram on symptoms of chest pain in patients with functional chest pain.
详细描述
Chest pain can be divided in cardiac or non-cardiac chest pain (NCCP). To establish the diagnosis NCCP, acute coronary disease has to be ruled out first. NCCP can be caused by functional chest pain (FCP). NCCP in the absence of musculoskeletal abnormalities, major esophageal motor disorders, gastroesophageal reflux or eosinophilic esophagitis is called FCP. The pathophysiology is not fully understood. Most likely multiple factors play a role, such as esophageal hypersensitivity and enhanced perception. Citalopram and other antidepressants are proven to be effective in the treatment of functional gastrointestinal disorders such as irritable bowel syndrome. However, available data regarding low dose antidepressants in functional chest pain is inconclusive. Moreover, all current evidence concerning the effect of low dose antidepressants in patients with functional chest pain is extracted from trials that pooled patients with different functional esophageal disorders. With this trial the investigators want to assess the effect of citalopram on symptoms of chest pain in patients with functional chest pain.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Written informed consent
- •Minimum age: 18 years
- •Functional chest pain according to Rome IV criteria
- •Ruled out cardiac origin of chest pain
- •ECG with corrected QT interval (QTc) within the normal range (<450ms male, <460ms female)
- •Symptoms of chest pain for at least 6 months
- •Frequency of symptoms at least once a week
- •Gastroduodenoscopy, high-resolution manometry and 24-hour pH-impedance monitoring need to have been performed recently.
排除标准
- •Currently using antidepressants
- •Contraindication for the use of SSRI
- •Already tried antidepressants off-label to treat chest pain
- •Known allergy to citalopram
- •Severe and clinically unstable concomitant disease
- •Pregnant, lactating or fertile women (without contraception)
研究组 & 干预措施
Citalopram 20mg
干预措施: Citalopram 20mg (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Global assessment of patient reported change in chest pain after 6 weeks of treatment.
时间窗: 6 weeks after start of the study
Patients will be asked; "Compared to the start of the treatment, how would you rate the chest pain now? * Completely resolved * Moderately better * Slightly better * No change * Slightly worse * Moderately worse * Much worse Patients who answered completely resolved or moderately better will be defined as treatment success.
次要结局
- Global assessment of patient reported change in chest pain after 12 weeks of treatment.(12 weeks after start of the study)
- Psychological comorbidity using the Hospital Anxiety and Depression Scale (HADS)(Baseline, 6 weeks and 12 weeks)
- Adverse events/side effects(Adverse event reporting period is defined as the period following time of written informed consent up to 3 months after end of the observation period.)
- Chest pain will be scored on a 0-10 visual analog scale (VAS-score)(Baseline, 6 weeks and 12 weeks)
- Symptom frequency(Daily diary during the entire duration of the study (12 weeks))
- Symptom severity(Daily diary during the entire duration of the study (12 weeks))
- Health related quality of life measured using 36-Item Short Form Health Survey (SF36)(Baseline, 6 weeks and 12 weeks)
研究者
Prof.dr. A.J. (Arjan) Bredenoord
Prof. dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)