NCT07848477Not yet recruiting
PROMOTE: Effects of 5-HT4 Agonism on Cognition and Sleep in Peopl With Low Mood
Investigating the Effect of 5-HT4 Receptor Agonism on Cognition and Sleep in People With Low Mood
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 23 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Jul 2028
- Lead sponsor
- University of Oxford
- Diseases
- Depression
- NCT number
- NCT07848477
What you commit to
- Study type: Interventional
- Planned participants: 60
- From Oct 2026 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- Known lactase deficiency or any other problem absorbing lactose, galactose, or glucose
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Warneford Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.