Effect of citalopram on chest pain in patients with achalasia

Phase 4

Recruiting

Conditions: 'achalasia'' and ''motility disorder esophagus''
10017977

Registration Number: NL-OMON48367

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 68

Inclusion Criteria

Written informed consent
Minimum age: 18 years
Diagnosed with achalasia type 1 or 2
Previously treated with pneumodilatation, Heller*s myotomy or POEM
>=3 months post-treatment for achalasia
Recurrent chest pain

Exclusion Criteria

Achalasia type 3 (**spastic type**)
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)
Medication-related (contra-indications for citalopram)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Global assessment of chest pain after 6 weeks of treatment with citalopram. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Symptom frequency and symptom severity score (calculated from symptom diary)<br /><br>• Health-related Quality of life (SF-36)<br /><br>• Achalasia-specific health-related quality of life (Ach-HRQL)<br /><br>• Hospital Anxiety and depression scale (HADS)<br /><br>• Symptom severity and time to perception during esophageal acid perfusion and<br /><br>during esophageal barostat balloon distension test (sub-study).<br /><br>• Adverse events/ complications/ side-effects </p><br>