A Phase 4 interventional study of Citalopram 20mg and Placebo Oral Tablet in GERD, sponsored by Universitaire Ziekenhuizen KU Leuven. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-12-05.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Phase 4, Interventional, and Treatment
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
Exclusion Criteria:
20mg, once a day
Drug: Citalopram 20mg
Once a day
Drug: Placebo Oral Tablet
Citalopram is taken once a day as an add-on to PPI treatment (2x/d).
Placebo is taken once a day as an add-on to PPI treatment (2x/d)
change in number of reflux episodes
The primary efficacy endpoint will be the change in number of reflux episodes assessed by 24 hour impedance-pH monitoring.
Time frame: 8 weeks
change in reflux parameters
change in reflux parameters (number of reflux episodes with a high proximal extent, volume exposure) assessed by 24 hour impedance-pH monitoring,
Time frame: 8 weeks
change in esophageal sensitivity
change in esophageal sensitivity assessed by multimodal esophageal stimulation procedure
Time frame: 8 weeks
change in symptom severity
change in symptom severity assessed by validated reflux questionnaires (ReQuest questionnaire and diaries). Patients will have to indicate the symptom occurence and symptom severity on a scale. Two words, on each site of the scale indicate their symptom severity (on the left "totally not present" on the right "very strong present"). A higher score represents a worse outcome.
Time frame: 8 weeks
Plan to share: No
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Universitaire Ziekenhuizen KU Leuven