Prucalopride and Cognition in Recovered Depression (NCT05220228) | Clinical Trial Compass
CompletedNot Applicable
Prucalopride and Cognition in Recovered Depression
United Kingdom50 participantsStarted 2022-01-04
Plain-language summary
The current study has two aims:
1. To test the effect of 5-HT4 receptor agonism on cognition (including memory, attention and cognitive control) in individuals with previous history of depression.
2. To explore if prucalopride has an effect on emotional processing biases consistent with its effects on serotonin.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant is willing and able to give informed consent for participation in the research
* Male or female
* Body mass index in the range of 18 to 33
* Not currently taking any medications (except for contraception), including being antidepressant free for at least three months
* Have at least two previous episodes of depression, and have been recovered from the most recent episode of depression for six months
* Current PHQ-9 score \< 10 (the cut off for DSM major depression)
Exclusion Criteria:
The participant may not enter the study if ANY of the following apply:
* Any current Axis 1 DSM-5 psychiatric disorder
* Any previous episode of a severe mental illness, other than Depressive Disorder. Comorbid Anxiety disorders will be allowed, but not OCD (Obsessive Compulsive Disorder) or PTSD.
* A first degree relative diagnosed with Bipolar Affective Disorder Type 1 or Schizophrenia
* Body Mass Index outside the range of 18 to 33 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.