Effect of citalopram on chest pain in patients with achalasia

Recruiting

Conditions: Achalasia

Registration Number: NL-OMON23216

Lead Sponsor: Amsterdam UMC (location AMC)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 48

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Written informed consent
- Minimum age: 18 years. Maximum age: 75 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
o Midline chest pain or discomfort that is not of burning quality
o At least 3 episodes per week of unexplained chest pain, for a minimum of 3 months.
o No significant stasis, defined as <2cm stasis after 5 minutes on timed barium esophagram
o At start of symptoms, no sign of reflux esophagitis on last esophagogastroduodenoscopy

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- 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 (contraindication for placebo or citalopram)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome is the global assessment of reduction of chest pain after 6 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
- 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>- Adverse events/ complications/ side-effects<br>- Patients estimation about the received treatment (‘’Which treatment did you think you’ve received?’’)