Effect of an antidepressant on chest pain in patients with achalasia
- Conditions
- Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]Achalasia is a motility disorder of the esophagus. Disappearance of myenteric neurons in the esophageal wall leads to failure of relaxation of the lower esophageal sphincter (LES) and impaired peristalsis. Symptoms of achalasia include dysphagia, regurgitation, chest pain and weight loss due to the stasis of food and liquids in the esophagus. Treatments effectively diminish the symptoms dysphagia and regurgitation, however have little effect on the occurrence of chest pain.
- Registration Number
- EUCTR2019-001202-14-NL
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 68
•Written informed consent
•Minimum age: 18 years
•Diagnosed with achalasia type 1 or 2, confirmed by high-resolution manometry
•Previously treated with pneumodilatation, Heller’s myotomy or POEM
•=3 months post-treatment for achalasia
•Recurrent chest pain
oMidline chest pain or discomfort that is not of burning quality
oAt least 3 episodes per week of unexplained chest pain, for a minimum of 3 months.
oNo significant stasis, defined as <2cm stasis after 5 minutes on timed barium esophagram
oAt start of symptoms, no sign of reflux esophagitis on last esophagogastroduodenoscopy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 68
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Achalasia type 3 (‘’spastic type’’) or spastic contractions on high-resolution manometry
•Surgery of the esophagus except Heller’s myotomy and POEM
•Currently using antidepressants
•Chest pain suspect of cardiac origin.
•Severe and clinically unstable concomitant disease (e.g. liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders)
•Pregnancy or lactation. A pregnancy test will be carried out prior to inclusion in the study. Female patients who are premenopausal and have a negative pregnancy test should be on an anticonceptive.
•Medication-related: Allergy to barium sulfate or contra-indications for citalopram use
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of citalopram, as compared to a placebo, on spontaneous chest pain episodes in patients with achalasia. ;<br> Secondary Objective: Secondary Objectives:<br> •To compare chest pain frequency, intensity and duration after treatment with citalopram or placebo.<br> •To evaluate the effect of treatment with citalopram or placebo on the health status, psychological state and anxiety of the patient.<br> •To assess the side-effects of the treatment with citalopram.<br> ;Primary end point(s): Global assessment of chest pain after 6 weeks of treatment with citalopram. ;Timepoint(s) of evaluation of this end point: After 6 weeks
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): •Symptom frequency and symptom severity score (calculated from symptom diary)<br> •Health-related Quality of life (SF-36)<br> •Achalasia-specific health-related quality of life (Ach-HRQL)<br> •Hospital Anxiety and depression scale (HADS)<br> •Symptom severity and time to perception during esophageal acid perfusion and during esophageal barostat balloon distension test (sub-study).<br> •Adverse events/ complications/ side-effects<br> ;Timepoint(s) of evaluation of this end point: The symptoms will be assessed daily using a symptom diary.