Prucalopride for low mood: testing a 5-HT4 receptor activator for cognition and sleep

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates the cognitive and sleep-related effects of the 5-HT4 receptor agonist prucalopride in adults with low mood or major depressive disorder. Participants are randomized to receive prucalopride or placebo, with sleep assessed at home using wearable chest patches and cognitive function evaluated through memory, attention, and executive function tasks. The trial uses an experimental medicine approach to determine if 5-HT4 receptor activation can modulate cognitive symptoms associated with depression. Eligible participants are 18-65 years old with a PHQ-9 score between 9 and 15 and BMI 18-35. The study is conducted at Warneford Hospital in Oxford, led by the University of Oxford.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.
* A first degree relative diagnosed with Bipolar Affective Disorder Type 1 or Schizophrenia
* Body Mass Index outside the range of 18 to 35 inclusive
* Any significant current medical condition likely to interfere with conduct of the study or analysis of data
* 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)
* 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)
* Past history of dependence to illicit substances, and any consumption of illicit substances in the three months prior to the study
* Currently pregnant, trying to get pregnant, or breast feeding
* Current, or a significant history of, gastro-intestinal disorder or irritable bowel syndrome
* Known lactase deficiency or any other problem absorbing lactose, galactose, or glucose
* Participation in a study that involves the use of a medication or novel vaccine within the last three months
* Participation in a study using the same tasks in the last year
* Any physical (including visual and auditory) or language impairment that would make complying with the study protocol challenging, including yellow/blue colourblindness
* 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 undergo cardiac monitoring
* Unable to wear the sleep patch device for full monitoring period
* Implanted neurostimulator or pacemaker

Where it's running

• Warneford Hospital
  Oxford, Oxfordshire, United Kingdom Recruiting

Study contacts

• Principal investigator: Susannah E Murphy, DPhil — Department of Psychiatry, University of Oxford
• Study coordinator: Susannah Murphy, PhD
• Email: susannah.murphy@psych.ox.ac.uk
• Phone: +441865618313

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.