Citalopram for Reflux Hypersensitivity and Functional Heartburn
Status:
Recruiting
Trial end date:
2021-04-01
Target enrollment:
Participant gender:
Summary
Citalopram is a drug used in the treatment of depressive episodes and belongs to the group of
selective serotonin reuptake inhibitors (SSRI). Serotonin is an important neurotransmitter
predominantly found in the brain and the gastrointestinal tract. Serotonin is associated with
psychological disorders, including anxiety and depression, and emotion regulation and it has
been shown that anxiety and depression are associated with increased severity of GERD-related
symptoms. Citalopram and other SSRI's elevate the concentration of serotonin by blocking the
reabsorption into the presynaptic neuron and thereby increasing the level of serotonin
available to bind the postsynaptic receptor. A recent study showed beneficial effects of
citalopram in patients with reflux hypersensitivity. However, there was no objective
measurement for reflux nor esophageal sensitivity during the treatment period. Moreover, the
effect of citalopram in patients with functional heartburn has not been studied so far.
Therefore, the inevestigators will conduct a randomized, parallel, placebo-controlled study
to evaluate the efficacy of citalopram on the improvement in symptom severity, reflux
parameters and esophageal sensitivity. 50 patients with reflux hypersensitivity and 50
patients with functional heartburn will receive either placebo or citalopram (Cipramil®) 20
mg as an add-on for a period of 8 weeks. Symptom severity will be assessed by a validated
reflux questionnaire (ReQuest questionnaire and diaries), reflux parameters by performing a
24 hour impedance-pH monitoring and esophageal sensitivity using the multimodal esophageal
stimulation paradigm