Clinical trial NCT05735756: Effect of Citalopram on Chest Pain in Patients With Functional Chest Pain
Official title: Effect of Citalopram on Chest Pain in Patients With Functional Chest Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Functional Chest Pain
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Global assessment of patient reported change in chest pain after 6 weeks of treatment.
timeFrame: 6 weeks after start of the study
Secondary outcomes:
measure: Global assessment of patient reported change in chest pain after 12 weeks of treatment.
timeFrame: 12 weeks after start of the study
measure: Symptom frequency
timeFrame: Daily diary during the entire duration of the study (12 weeks)
measure: Symptom severity
timeFrame: Daily diary during the entire duration of the study (12 weeks)
measure: Chest pain will be scored on a 0-10 visual analog scale (VAS-score)
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Health related quality of life measured using 36-Item Short Form Health Survey (SF36)
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Psychological comorbidity using the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Adverse events/side effects
timeFrame: 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.
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
state: Noord-Holland
Study officials:
References: