To assess the effect of citalopram on symptoms of chest pain in patients with functional chest pain.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Global assessment of patient reported reduction in chest pain after 6 weeks of
treatment.
Secondary outcome
Global assessment of patient reported reduction in chest pain after 12 weeks of
treatment.
Symptom severity and frequency
Health status and quality of life (SF-36)
Psychological comorbidity (HADS)
Adverse events/side effects
Background summary
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.
Study objective
To assess the effect of citalopram on symptoms of chest pain in patients with
functional chest pain.
Study design
A single center, double-blind placebo-controlled randomized trial.
Intervention
During the study period of twelve weeks, patients will either receive daily 20
mg of citalopram or a placebo.
Study burden and risks
Citalopram has been studied extensively in the past decades, mainly for its use
in major depressive disorders. Citalopram is an antidepressant in the group of
selective serotonin reuptake inhibitors (SSRIs). In addition to its effect as
antidepressant the effect of citalopram in functional gastrointestinal
disorders such irritable bowel disease has also been proven. Citalopram and
other SSRIs are frequently being prescribed off-label in the same dosage in
patients with functional chest pain making the risk of this study negligible
over routine clinical care. 20 mg of citalopram is a low dose, so only minor
side effects are being expected.
The burden for the participating patients consists of one extra visit to the
hospital, 2 phone calls, filling-out questionnaires at the start, after 6 weeks
and at the end of the study, and filling-out a daily symptom diary.
Stopping therapy without tapering off the antidepressant may result in
withdrawal symptoms such as headaches, nausea, sweating or insomnia. The chance
of developing withdrawal symptoms is higher after long term use of
antidepressants. Since we only treat the patients for twelve weeks, we estimate
this as low risk. However, patients will be instructed to contact the
investigators when these symptoms occur after ceasing treatment.
In conclusion, citalopram and other SSRIs are already being used off-label in
patients with functional chest pain, however a randomized controlled trial
never has been done. Therefore there is no additional risk for patients
participating in this study compared to daily clinical practice. No additional
investigations are needed before patients can participate since all
investigations are already done as part of clinical routine
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2021-002288-24-NL |
CCMO | NL77673.018.21 |