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The clinical trial has ended prematurely due to low patient recruitment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Citalopram 20mg | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citalopram 20mg | Drug | Citalopram 20mg once a day for 12 weeks |
| |
| 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?
| 6 weeks after start of the study |
| 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?
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC, location AMC | Amsterdam | North Holland | 1105AZ | Netherlands |
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| ID | Term |
|---|---|
| D015283 | Citalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Placebo |
| Drug |
Placebo once a day for 12 weeks |
|
| 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. |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |