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Effect of Citalopram on Chest Pain in Patients With Functional Chest Pain (Ci-FCP)

A

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status and phase

Terminated
Phase 4

Conditions

Functional Chest Pain

Treatments

Drug: Placebo
Drug: Citalopram 20mg

Study type

Interventional

Funder types

Other

Identifiers

NCT05735756
NL77673.018.21

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1 participants in 2 patient groups, including a placebo group

Citalopram 20mg
Active Comparator group
Treatment:
Drug: Citalopram 20mg
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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