Study of citalopram effectiveness in reducing chest pain for adults with achalasia

3 1 1

What is this study about?

Achalasia is a condition where the muscles of the lower esophagus (food pipe) do not relax properly, making it difficult to swallow food and causing chest pain. This study focuses on testing citalopram, a medication typically used for depression, to see if it can help reduce chest pain in people who have already received treatment for achalasia but still experience pain.

The study will compare citalopram tablets with a placebo to determine if the medication is effective in reducing chest pain episodes in achalasia patients. Each participant will receive either a 20-milligram citalopram tablet or a placebo tablet to take daily for 6 weeks.

Throughout the study, participants will keep track of their symptoms and complete various questionnaires about their pain levels and overall well-being. The researchers will monitor how the medication affects chest pain relief and any potential side effects that may occur during the treatment period.

1 Initial treatment phase

You will receive either citalopram (20 mg film-coated tablet) or a placebo (inactive substance that looks identical to the real medication).

The medication needs to be taken by mouth once daily for 6 weeks.

Neither you nor your doctor will know which treatment you are receiving during this period.

2 Symptom monitoring

Throughout the 6-week period, you will need to maintain a symptom diary to record:

The frequency of chest pain episodes

The severity of your symptoms

3 Quality of life assessments

You will complete several questionnaires during the study:

General health and well-being assessment (SF-36)

Specific questions about living with achalasia

Questions about anxiety and mood

4 Final evaluation

After 6 weeks, your doctor will evaluate how much your chest pain has improved

You will be asked which treatment you think you received

Any side effects or complications will be recorded

5 Optional sub-study

Some participants may be invited to participate in additional tests:

An esophageal acid test to measure symptom perception

A balloon test to measure pressure sensitivity in the esophagus

Who Can Join the Study?

Patient must provide written consent to participate in the study
Age must be between 18 and 75 years
Must have confirmed diagnosis of type 1 or 2 achalasia through a special pressure test of the esophagus (high-resolution manometry)
Must have previously received one of these treatments:
– Balloon dilation of the esophagus (pneumodilatation)
– Surgical procedure to relax the esophagus muscle (Heller’s myotomy)
– Endoscopic procedure through the mouth (POEM)
At least 3 months must have passed since the last treatment
Must experience chest pain or discomfort in the middle of the chest that does not feel like burning
Must have at least 3 episodes of unexplained chest pain per week for at least 3 months
Must show minimal food retention in the esophagus (less than 2cm stasis after 5 minutes on special X-ray test)
Must have had an endoscopy examination (camera test of the esophagus) within the last 5 years showing no signs of inflammation due to acid reflux

Who Cannot Join the Study?

Current use of medications that could interact with citalopram (an antidepressant medication)
History of heart rhythm problems or cardiac conduction abnormalities (problems with electrical signals in the heart)
Pregnant or breastfeeding women
Current diagnosis of major depression or other significant psychiatric disorders
Known allergic reactions to citalopram or similar medications
Severe liver or kidney disease
Use of other medications that affect serotonin levels in the body
Recent surgery on the esophagus (food pipe)
Participation in other clinical trials within the past 30 days
Inability to provide informed consent
Substance abuse within the past 6 months
Uncontrolled medical conditions that could interfere with the study results
History of bleeding disorders or current use of blood thinners
Severe esophageal complications (serious problems with the food pipe)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Asqmesegf Uib	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	14.10.2019

Trial locations

Investigated drugs:

Citalopram

Citalopram is an antidepressant medication that belongs to a group called selective serotonin reuptake inhibitors (SSRIs). In this trial, it is being studied for its potential effects on chest pain in patients with achalasia, a condition that affects the esophagus. While typically used to treat depression and anxiety, researchers are investigating whether this medication can help reduce the frequency and intensity of chest pain episodes that are common in people with achalasia.

Investigated diseases:

Oesophageal achalasia

Achalasia – A rare digestive disorder where the muscles in the lower esophagus fail to relax properly during swallowing. In this condition, the ring of muscle between the esophagus and stomach (lower esophageal sphincter) doesn’t open as it should, making it difficult for food and liquids to pass into the stomach. The esophagus also loses its ability to squeeze food down toward the stomach in a normal way. Over time, food can collect in the esophagus, causing symptoms such as difficulty swallowing, chest pain, regurgitation of food, and heartburn.

Trial ID:

2024-517701-81-01

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of citalopram effectiveness in reducing chest pain for adults with achalasia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?