Testing prucalopride effects on sleep and thinking in people with low mood
Tests prucalopride against placebo in adults with low mood or depression.
Plain-language title generated from the registry record
Registry title: PROMOTE: Effects of 5-HT4 Agonism on Cognition and Sleep in Peopl With Low Mood
Key facts
- Where
- Oxford, United KingdomSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07848477, who can take part
Where in United Kingdom
- Warneford HospitalOxford, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Oxford
- Trial code
- NCT07848477
- Record updated
- 9 November 2026
- Original description
Serotonin is a chemical in the brain that plays an important role in mood, sleep, and other functions. It works by attaching to different types of serotonin receptors on brain cells. These receptors act like "locks", with serotonin acting like a "key". Different types of serotonin receptors have different effects in the brain.Read full original descriptionShow less
Investigating the Effect of 5-HT4 Receptor Agonism on Cognition and Sleep in People With Low Mood
Serotonin is a chemical in the brain that plays an important role in mood, sleep, and other functions. It works by attaching to different types of serotonin receptors on brain cells. These receptors act like "locks", with serotonin acting like a "key". Different types of serotonin receptors have different effects in the brain.
Prucalopride is a licensed medication used to treat constipation. It acts on a particular serotonin receptor, called the serotonin 4 receptor. Researchers are interested in this receptor because understanding how it works in the brain may help us learn more about depression and could contribute to the development of new treatments in the future.
The purpose of this study is to investigate the effects of prucalopride in people experiencing low mood. We will compare prucalopride with a placebo (a treatment with no active medication) to find out whether activating the serotonin 4 receptor affects sleep and aspects of thinking, including memory, attention and decision making.
Inclusion: Aged between 18-65; Male or female; Participant is willing and able to give informed consent for participation in the research; Body mass index in the range of 18-35 inclusive; Current PHQ-9 score in the range of 9-15.
Exclusion: Any current or previous episode of a severe mental illness, other than Depressive Disorder. Comorbid Anxiety disorders will be allowed, but not OCD or PTSD; Current use of psychoactive and / or medically significant medication as judged by a study medic, whether prescribed or bought over the counter (the contraceptive pill, the Depo-Provera injection or the progesterone implant will not result in exclusion); Past history of dependence to illicit substances, and any consumption of illicit substances in the three months prior to the study; Participation in a study that involves the use of a medication or novel vaccine within the last three months; A first degree relative diagnosed with Bipolar Affective Disorder Type 1 or Schizophrenia; Any significant current medical condition likely to interfere with conduct of the study or analysis of data; Current, or a significant history of, gastro-intestinal disorder or irritable bowel syndrome; Any physical (including visual and auditory) or language impairment that would make complying with the study protocol challenging, including yellow/blue colourblindness; Unable to undergo cardiac monitoring; Known lactase deficiency or any other problem absorbing lactose, galactose, or glucose; Body Mass Index outside the range of 18 to 35 inclusive; Ongoing psychopharmacological treatment for depression, including hypnotics (psychotherapy will be allowed as long as not newly-started in the last 6 weeks); High consumption of illicit substances to an extent that would make complying with study protocol challenging (including alcohol, caffeine, nicotine); Currently pregnant, trying to get pregnant, or breast feeding; Participation in a study using the same tasks in the last year; A head injury causing concussion or loss of consciousness within the last six months; Moderate to high risk of suicide or self-harm; Participant who is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the Chief Investigator; Additional Exclusion Criteria for Participants in the Sleep Study Cohort:; Unable to wear the sleep patch device for full monitoring period; Implanted neurostimulator or pacemaker.