Not yet recruitingNAINTERVENTIONAL

PROMOTE: Effects of 5-HT4 Agonism on Cognition and Sleep in Peopl With Low Mood

This research, called PROMOTE, is looking into how a medicine called prucalopride affects people who are experiencing low mood. Prucalopride is already used for constipation, but it also works on a specific chemical system in the brain called the serotonin 4 receptor. Serotonin is a brain chemical important for mood and sleep. Researchers believe that understanding this specific receptor could lead to new ways to help with depression. The study will compare prucalopride with a 'dummy' pill (placebo) to see if activating this receptor can improve sleep and thinking skills like memory, attention, and decision-making in people with low mood. This helps pave the way for potential future treatments.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University of Oxford

Enrolment target

Start

01 Oct 2026

Estimated completion

01 Jul 2028

Low Mood Depression - Major Depressive Disorder

What is this study about?

Many people with depression find it hard to think clearly, even when their mood starts to get better. This can include problems with memory, paying attention, and making decisions. We urgently need new ways to help with these thinking difficulties.

Our brains use chemicals called neurotransmitters, like serotonin, to communicate. Serotonin acts like a 'key' that fits into different 'locks' on brain cells, called receptors. Prucalopride is a medicine currently used for constipation, but it specifically targets one of these 'locks' – the serotonin 4 receptor. Previous research has shown that this receptor might be important for thinking and memory. We've already seen some promising effects of prucalopride on thinking skills in healthy people and those who have recovered from depression.

This study aims to take the next step by looking at prucalopride in people who are currently experiencing low mood. We want to see if activating the serotonin 4 receptor can improve their thinking skills and sleep. To do this, some participants will receive prucalopride, while others will get a placebo (a pill with no active medicine). We will measure changes in thinking abilities and track sleep patterns at home using special wearable sensors. The information we gather will be crucial in deciding if this medicine could be a promising new treatment for depression that affects thinking and sleep.

Key takeaways

This study investigates a licensed constipation medicine, prucalopride, for depression.
It focuses on how prucalopride affects mood, sleep, and thinking skills.
The study uses a placebo to compare effects fairly.
Participation involves taking pills, attending visits, and wearing a sleep monitor.
It aims to find new ways to treat depression, especially thinking difficulties.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for volunteers who are between 18 and 65 years old and are currently experiencing low mood. You would need to have a body mass index (BMI) between 18 and 35. You also need to be willing and able to understand what the study involves and give your permission to take part.

There are several reasons why you might not be able to join. For example, if you have a severe mental illness other than depression (like bipolar disorder or schizophrenia), or if a close family member has been diagnosed with these conditions. We also can't include people with certain ongoing medical conditions, severe digestive problems, or if you are currently taking medications that might affect the study results, including antidepressants or strong sleeping pills.

Additionally, you cannot take part if you are pregnant, trying to get pregnant, or breastfeeding. People who have used illicit substances heavily in the past or recently, or those who have certain language or physical impairments that would make it hard to follow the study instructions, would also not be eligible.

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 between 18 and 65 years old?
Do you currently have low mood or symptoms of depression?
Do you have a Body Mass Index (BMI) between 18 and 35?
Are you NOT pregnant, trying to get pregnant, or breastfeeding?
Are you NOT currently taking antidepressants or strong sleeping pills?
Do you NOT have a history of severe mental illness (other than depression) or severe digestive problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given either prucalopride or a placebo (a dummy pill) to take. You will need to attend several visits to the study clinic where we will ask you questions about your mood and how you are feeling. We will also ask you to complete tasks designed to test your memory, attention, and decision-making skills. To measure your sleep, you will wear a special sensor at home. The exact number of visits and the total length of your participation will be explained in detail by the study team, but generally, these types of studies involve a few weeks or months of commitment.

Potential risks and benefits

Taking part in this study could offer some potential benefits. You might experience an improvement in your mood, sleep, or thinking skills, though we cannot guarantee this. You would also be contributing to important research that could help develop new treatments for depression in the future. As with any medication, there's a chance of side effects from prucalopride, which the study team will discuss with you. You might also find the study visits or tests tiring. It's important to remember that taking part is entirely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Warneford Hospital
Verified postcode
Oxford, United Kingdom

Common questions

What is prucalopride?

Prucalopride is a medicine that is already approved for treating constipation. This study is exploring if it can also help with low mood, sleep, and thinking.

What is a placebo?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active drug. This helps us compare the effects of the medicine accurately.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor the study team will know who is getting the real medicine and who is getting the placebo during the study. This helps keep the results fair.

What does 'low mood' mean in this study?

For this study, 'low mood' refers to symptoms of depression, which will be assessed using a standard questionnaire to ensure you meet the study's criteria.

Will this study help me with my current depression?

This is a research study to understand a potential new approach. While some participants may feel better, we cannot promise any specific health benefits. Your participation helps advance medical knowledge.

How to find out more

Susannah Murphy, PhD

susannah.murphy@psych.ox.ac.uk +441865618313 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.