Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Effect of citalopram on chest pain in patients with achalasia.

This research study is investigating if a medication called citalopram can ease chest pain in people who have achalasia. Achalasia is a condition affecting how food moves down the gullet (oesophagus). The study plans to give some participants citalopram and others a placebo (a dummy pill with no active medicine) for a period of six weeks. Researchers will then check if those taking citalopram report feeling less chest pain. They will also look at how often symptoms occur, how severe they are, and how the participants' general health and quality of life are affected. This is a Phase IV study, meaning the medicine is already approved for other uses, and this research is looking at a new potential use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Amsterdam UMC Stichting

Enrolment target

Start

23 Dec 2024

Achalasia

What is this study about?

This study is designed to find out if citalopram, a medication sometimes used for other conditions, can help people who experience chest pain due to achalasia. Achalasia is a problem with the gullet (the tube that carries food from your mouth to your stomach), where the muscles don’t work properly to push food down, and the valve at the bottom doesn’t open well. This can lead to difficulties swallowing and often causes chest pain.

The main goal of this research is to see if participants feel a significant improvement in their chest pain after taking citalopram for six weeks, compared to those who take a placebo (a pill that looks the same but contains no medicine). This will help doctors understand if citalopram could be a useful treatment option for this specific symptom of achalasia. It's important to remember that this study is not looking at curing achalasia itself, but rather at managing the chest pain it can cause.

Beyond just pain relief, the researchers will also be checking other aspects. They'll ask about how often participants have symptoms, how severe these symptoms are, and how their daily life and general well-being are affected. They'll also look at how anxiety and depression might change, as well as keeping a close eye on any side effects that might occur. This comprehensive approach helps build a complete picture of citalopram's potential effects for people with achalasia.

Key takeaways

This study evaluates citalopram for achalasia-related chest pain.
Participants will receive either citalopram or a placebo for six weeks.
The main goal is to assess chest pain relief.
Other factors like quality of life and side effects will also be monitored.
Participation involves taking medication and completing diaries/questionnaires.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adult volunteers, aged 18 years or older, regardless of whether they are male or female. The main requirement is that you have been diagnosed with achalasia and are experiencing chest pain related to this condition.

There might be specific health conditions or medications that would prevent you from taking part, to ensure your safety. For example, if you have certain heart problems, kidney issues, or are taking medications that could interact with citalopram, you might not be able to join. All participants will undergo checks to make sure the study is safe for them.

Because this is a research study, only people who meet all the strict criteria can join. This helps make sure the results are clear and reliable. If you're interested, the study team will go through a full list of these requirements with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with achalasia?
Do you experience chest pain due to your achalasia?
Are you able to attend appointments and complete questionnaires?
Do you have any significant heart, liver, or kidney problems?
Are you taking any medications that might interact with citalopram (the study team will check this)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to either receive the study medicine (citalopram) or a placebo (a dummy pill). You won't know which one you are getting, and neither will your doctor, which helps keep the results unbiased. You will take the assigned pills for six weeks.

Throughout the study, you will be asked to keep a diary of your symptoms, noting how often you experience chest pain and how severe it is. You will also complete some questionnaires about your general health, quality of life, and mood. There will be regular visits or calls with the study team to monitor your progress, check for any side effects, and collect information. These checks might include specific tests to understand your achalasia symptoms better.

Overall, your total participation in the study, including follow-up, will be clearly explained. You would expect to have initial assessments, six weeks of treatment, and then follow-up assessments to see how you are doing.

Potential risks and benefits

Participating in this study might offer you the potential benefit of reducing your chest pain if you receive the active medicine, citalopram. Even if you receive the placebo, your condition will be closely monitored by the study team, and you'll be contributing valuable information that could help others with achalasia in the future. However, there are potential risks, as citalopram can have side effects, just like any medication. These can vary from person to person but could include things like nausea, dizziness, or changes in sleep. The study team will explain all known potential side effects to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is achalasia?

Achalasia is a condition where the muscles in your gullet (oesophagus) don't work properly, making it hard for food to pass into your stomach. It can cause problems like difficulty swallowing and chest pain.

What is citalopram?

Citalopram is a medication currently approved for treating conditions like depression. This study is exploring if it could also help with chest pain in people with achalasia.

What is a placebo?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It's used in studies to compare the effects of the active medicine against no treatment.

How long will I take the study medicine?

If you join the study, you will take the assigned pills (either citalopram or placebo) for a period of six weeks.

What if I feel worse during the study?

The study team will be monitoring you closely. If you feel worse or have any concerns, you should tell them immediately. You can also leave the study at any time.