Effect of Citalopram on Chest Pain in Patients With Functional Chest Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Citalopram on Chest Pain in Patients With Functional Chest Pain

Conditions
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Functional Chest Pain

Intervention / Treatment
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* Drug: Citalopram 20mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Citalopram 20mg<br> | Drug: Citalopram 20mg<br>* Citalopram 20mg once a day for 12 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo once a day for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global assessment of patient reported change in chest pain after 6 weeks of treatment. | 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. | 6 weeks after start of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global assessment of patient reported change in chest pain after 12 weeks of treatment. | 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. | 12 weeks after start of the study | 
| Symptom frequency | Patients are asked to report the frequency of symptom episodes on a daily base | Daily diary during the entire duration of the study (12 weeks) | 
| Symptom severity | Patients are asked to report the severity of every symptom episode on a daily base. The severity will be rated on a 4-point scale: mild (1, the symptom was well tolerated and did not last long) moderate (2, the symptom caused some discomfort, but did not interfere with usual activities), severe (3, the symptom caused a great deal of discomfort, and interfered with usual activities), disabling (4, the symptom was unbearable and interfered considerably with usual activities). | Daily diary during the entire duration of the study (12 weeks) | 
| Chest pain will be scored on a 0-10 visual analog scale (VAS-score) | Patients are asked to report the severity of the chest pain every 6 weeks | Baseline, 6 weeks and 12 weeks | 
| Health related quality of life measured using 36-Item Short Form Health Survey (SF36) | The health related quality of life is measured every 6 weeks | Baseline, 6 weeks and 12 weeks | 
| Psychological comorbidity using the Hospital Anxiety and Depression Scale (HADS) | Psychological comorbidity is assessed every 6 weeks | Baseline, 6 weeks and 12 weeks | 
| Adverse events/side effects | Patients are asked to report adverse events and 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. |