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

NL77673.018.21

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.

2022-01-17

2022-04-22

2022-04-22

Terminated

Early phase I

1

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1, 'type': 'ACTUAL'}}

2023-02-21