AuthorisedTherapeutic exploratory (Phase II)Interventional

Etude de phase II évaluant la capacité d'un agoniste des récepteurs 5-HT4, le prucalopride (Resolor©), à accélérer l'efficacité thérapeutique d'un antidépresseur de type ISRS: preuve de concept clinique.

This study is investigating if a medication called prucalopride can help people with depression get better more quickly when used alongside their usual antidepressant, escitalopram. Depression can be a tough journey, and finding ways to speed up recovery is really important. Participants will be placed into one of two groups: one group will take escitalopram plus prucalopride, and the other will take escitalopram plus a 'dummy' pill (placebo). Over six weeks, doctors will keep track of how people's depression symptoms change using several common questionnaires. They will also monitor for any side effects and see how people's anxiety, emotions, and memory are affected. The main aim is to see if adding prucalopride makes a noticeable difference to how quickly people start to feel better.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Universitaire Grenoble Alpes

Enrolment target

Start

16 Sep 2025

Dépression

What is this study about?

When people are feeling down with depression, it's really important to find treatments that work well and, ideally, help them feel better as quickly as possible. This study is exploring a new idea: could adding an existing medication, called prucalopride, to a common antidepressant help people recover faster? Researchers already know that prucalopride can affect certain chemical messengers in the brain and gut, and they're wondering if this effect could also help with depression.

This is a 'Phase II' study, which means it's an early investigation to see if there's a promising sign that this combination treatment could work. It's not a large study designed to prove it definitely works, but rather to see if it's worth studying in bigger trials later on. The main goal is to compare two groups of people with depression. Both groups will take a standard antidepressant called escitalopram. One group will also take prucalopride, while the other will take a 'dummy' pill (a placebo) that looks the same but contains no active medicine. This allows researchers to see if any improvements are genuinely due to the prucalopride or if they happen anyway.

Over six weeks, the research team will regularly check in with participants to understand how their depression symptoms are changing. They'll use well-known questionnaires to measure mood and anxiety levels. They'll also record any side effects and even look at things like how people recognise emotions or remember things. This detailed information will help them understand if prucalopride, when added to an antidepressant, helps people feel better more quickly and if it's generally well-tolerated.

Key takeaways

This study evaluates if adding prucalopride to an antidepressant (escitalopram) helps depression sooner.
It's a six-week study, comparing prucalopride plus escitalopram against a placebo plus escitalopram.
Researchers will track changes in mood, anxiety, and side effects.
Participants will have regular clinic visits and take study medication.
It's a 'Phase II' study, looking for early signs of effectiveness.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would generally need to be an adult, aged 18 or older. The study is open to both men and women.

The most important requirement is that you have been diagnosed with depression. The doctors involved in the study will need to confirm your diagnosis and make sure your specific situation fits the study's criteria.

Beyond having depression, there will be other medical checks to make sure the study is safe and suitable for you. These checks will make sure you don't have other health conditions or are taking medications that might interfere with the study drugs or your safety.

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 depression?
Are you currently suitable to take escitalopram?
Are you able to attend appointments regularly for six weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to make sure you're a good fit. If eligible, you would then be randomly assigned to one of two groups: one taking the antidepressant escitalopram plus prucalopride, and the other taking escitalopram plus a dummy pill (placebo).

The study would last about six weeks in total. During this time, you would have several visits to the clinic. At these visits, doctors and nurses would check your health, ask you questions about your mood and how you're feeling using special questionnaires, and monitor for any side effects. These check-ups would happen on specific days, including days 3, 7, 14, 28, and 42 after starting your study medication.

You would take your study medication (either prucalopride or the placebo, in addition to escitalopram) as instructed. They would also keep an eye on how well you're taking your medication. Some visits might also include special tests looking at emotional recognition and memory. You would have the right to withdraw from the study at any time.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that adding prucalopride might help you feel better from depression more quickly than taking escitalopram alone. However, there's no guarantee that you will personally benefit, and you might receive the dummy pill. Like all medications, prucalopride and escitalopram can have side effects. The study will carefully monitor for common side effects like tiredness, tummy upsets, or headaches, among others. You will be closely monitored by the study team, and you are free to leave the study at any time, for any reason, without it affecting your 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
France

Common questions

What is prucalopride?

Prucalopride is a medication that affects certain chemical messengers in the body, primarily known for helping with constipation. This study is exploring if it could also help with depression.

What is escitalopram?

Escitalopram is a commonly prescribed antidepressant medication that helps to improve mood by balancing certain chemicals in the brain.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the real medication but contains no active ingredients. It helps researchers see if a treatment is truly effective or if improvements are due to other factors.

How long will the study last if I join?

The main part of the study where you take medication and have regular check-ups will last for about six weeks.

Will I know if I'm taking prucalopride or the placebo?

No, this is a 'blinded' study, meaning neither you nor the study doctors will know whether you are receiving prucalopride or the placebo until after the study has finished. This helps ensure the results are as fair as possible.