An interventional study of Prucalopride and Placebo Comparator in Low Mood and Depression - Major Depressive Disorder, sponsored by University of Oxford. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by University of Oxford · Not applicable, Interventional, and Basic science
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Among 21 studies in Consciousness Disorders with a site in United Kingdom — 4 open to participants now, 4 under way, none of them phase 3. Consciousness Disorders · United Kingdom.
Among the 21 studies in Consciousness Disorders with a site in United Kingdom, this one is the 9th largest by planned enrollment of the 17 interventional ones that give a count, is the only one that started in 2026, is one of 15 with no phase, and was the 21st registered.
290 studies on the registry are indexed under Consciousness Disorders; 109 are open to participants now.
Browse Consciousness Disorders studies →4 of the 21 studies in Consciousness Disorders with a site in United Kingdom are open now. Recruiting first, the newest first:
University of Nottingham · Sites in United Kingdom
Ages 18+ · Healthy volunteers
The Children's Trust, United Kingdom · Sites in United Kingdom, United States
Ages 2–18
University of Ulster · Sites in United Kingdom, Ireland
Ages 10–80
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 73 Consciousness Disorders studies recruiting now, 29 (40%) set no upper age limit and 25 (34%) stop at 75 or younger; 11 take children under 18; 14 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is above the median of 47 across 191 interventional studies indexed under Consciousness Disorders.
Median enrollment 60 across the 17 interventional studies, 60 across the 4 observational. Of the 11 that completed or were terminated, 0 (0%) have results posted.
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2 of 21 have an industry lead sponsor. The 10 most frequent:
University of Oxford is the lead sponsor of 813 studies on the registry; 120 are open to participants now.
University of Oxford has 3 studies filed under Consciousness Disorders — fewer than ten, so there is no comparison to draw.
2 of the studies in Consciousness Disorders with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04050995The Children's Trust, United KingdomEvaluation of the MuSICCA for Measuring Awareness | 2026-12-01 |
| NCT06647433University of NottinghamWhat is the Perceived Role of Risk in DOC Healthcare. | 2027-01 |
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Among the 21 studies in Consciousness Disorders with a site in United Kingdom, from their registry updates:
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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.
Cognitive symptoms are common in depression and can persist even when other symptoms of depression have improved. These difficulties can include impairments in memory, attention and executive function, and there remains a need for treatments that specifically target cognitive dysfunction associated with depression.
Evidence from preclinical and human experimental studies suggests that activation of the serotonin 4 receptor (5-HT4R) may represent a potential therapeutic approach for targeting cognitive symptoms in depression. The 5-HT4R is expressed in brain regions involved in learning and memory, and experimental studies have investigated whether selective activation of this receptor can influence cognitive processes relevant to depression.
Prucalopride is a selective 5-HT4R agonist. In previous human experimental studies, we have found evidence that prucalopride can influence cognitive processes, including learning and memory, in healthy volunteers and people who have recovered from depression. The present study extends this work by investigating the cognitive effects of prucalopride in people who are currently experiencing low mood.
The study will use an experimental medicine approach to examine the effects of 5-HT4R activation on cognitive processes relevant to depression. In addition, the study will investigate the effect of prucalopride on sleep architecture. Sleep will be assessed in the home environment using wearable chest patches capable of sleep staging.
The study will provide proof-of-concept evidence regarding the effects of 5-HT4R activation on cognition and sleep in people experiencing low mood. These data will inform the design and feasibility of a future randomised controlled trial evaluating prucalopride in people with depression and cognitive impairment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Additional Exclusion Criteria for Participants in the Sleep Study Cohort:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive daily oral prucalopride for 14 days.
Drug: Prucalopride
Participants will receive daily oral placebo for 14 days.
Drug: Placebo Comparator
Prucalopride will be administered orally once daily for 14 days. Participants will receive 1 mg once daily on Days 1-2 and 2 mg once daily on Days 3-14.
A matching placebo (lactose) will be administered orally once daily for 14 days. Participants will take one placebo capsule on Days 1-2 and two placebo capsules on Days 3-14, matching the dosing schedule of the prucalopride intervention.
Auditory Verbal Learning Test (AVLT)
Verbal learning and memory will be assessed using the Auditory Verbal Learning Test, including measures of immediate recall, delayed recall, and recognition memory. AVLT performance will be compared between prucalopride and placebo groups following the intervention.
Time frame: Day 14 (post-intervention)
Sleep outcomes measured using wearable sleep monitoring
Sleep will be assessed using a wearable chest patch in a subset of participants (n=20 total, 10 per intervention group). Measures will include sleep duration, sleep quality and sleep staging. Sleep outcomes will be compared between the prucalopride and placebo groups.
Time frame: Baseline (Day 0) and Days 1-4 of the intervention
Digit Span Task
Maximum digit span will be assessed as a measure of working memory and compared between the prucalopride and placebo groups
Time frame: Baseline and Day 14 (post-intervention)
Emotional Go/No-Go (EGNG)
Inhibitory control will be assessed using the EGNG task, including measures of commission errors, omission errors, and reaction time. Performance will be compared between prucalopride and placebo groups follwing the intervention.
Time frame: Day 14 (post-intervention)
Probabilistic Reversal Learning Task (PRL)
Cognitive flexibility and reward-based learning will be assessed using the PRL task, including measures such as response accuracy, reversal errors, and sensitivity to reward and punishment. Performance will be compared between prucalopride and placebo groups following the intervention.
Time frame: Day 14 (post-intervention)
Mnemonic Similarity Task (MST)
Pattern separation and recognition memory will be assessed using the MST. Performance will be compared between the prucalopride and placebo groups following the intervention.
Time frame: Day 14 (post-intervention)
Serial Addition Task (SAT)
Working memory will be assessed using the SAT. Performance will be compared between the prucalopride and placebo groups following the intervention
Time frame: Day 14 (post-intervention)
Matrix Span Task
Visual working memory assessed using the Matrix Span Task, administered remotely via the NeuroUX app. Performance (accuracy/reaction time) will be compared between prucalopride and placebo groups.
Time frame: Baseline and Days 2, 3, 5, 6, 8, 10, 11 and 13 of the 14-day intervention.
Variable Difficulty List Memory Test (VDLMT)
Verbal learning and recognition memory will be assessed using the VDLMT, administered remotely via the NeuroUX app. Performance will be compared between the prucalopride and placebo groups.
Time frame: Baseline and Days 1, 2, 4, 6, 7, 9, 11, 12 and 14 of the 14-day intervention.
N-Back Test
Working memory will be assessed using the 2-back version of the N-back task, administered remotely via the NeuroUX app. Performance will be compared between the prucalopride and placebo groups.
Time frame: Baseline and Days 1, 3, 4, 6, 8, 9, 11, 13 and 14 of the 14-day intervention.
Digit Symbol Substitution Task (DSST)
Processing speed will be assessed using the DSST, administered remotely via the NeuroUX app. Performance will be compared between the prucalopride and placebo groups.
Time frame: Baseline and Days 1, 3, 5, 7, 8, 10, 12 and 13 of the 14-day intervention.
Quick Tap 2 Test
Response inhibition will be assessed using the Quick Tap 2 test, a go/no-go task administered remotely via the NeuroUX app. Performance will be compared between the prucalopride and placebo groups.
Time frame: Baseline and Days 2, 4, 5, 7, 9, 10, 12 and 14 of the 14-day intervention.
Paired Associates Learning (PAL)
Verbal associative and episodic memory will be assessed using the PAL task. Performance will be compared between the prucalopride and placebo groups.
Time frame: Day 14 (post-intervention)
State Subjective Cognition Scale (SSCS)
Subjective cognitive functioning will be assessed using the State Subjective Cognition Scale (SSCS). Responses will be compared between the prucalopride and placebo groups.
Time frame: Baseline and daily during the 14-day intervention.
Positive and Negative Affect Schedule (PANAS)
Positive and negative affect will be assessed using the PANAS. Scores will be compared between the prucalopride and placebo groups.
Time frame: Baseline and daily during the 14-day intervention.
Patient Health Questionnaire-9 (PHQ-9)
Depressive symptoms will be assessed using the PHQ-9. Scores will be compared between the prucalopride and placebo groups.
Time frame: Baseline, Day 7 and Day 14 of the intervention
Perceived Deficits Questionnaire (PDQ)
Subjective cognitive difficulties will be assessed using the PDQ. Scores will be compared between the prucalopride and placebo groups.
Time frame: Baseline, Day 7 and Day 14 of the intervention
Generalized Anxiety Disorder-7 (GAD-7)
Anxiety symptoms will be assessed using the GAD-7. Scores will be compared between the prucalopride and placebo groups.
Time frame: Baseline, Day 7 and Day 14 of the intervention.
Temporal Experience of Pleasure Scale (TEPS)
Anticipatory and consummatory pleasure will be assessed using the TEPS. Scores will be compared between the prucalopride and placebo groups.
Time frame: Baseline, Day 7 and Day 14 of the intervention.
Plan to share: Yes — Anonymised individual participant data (IPD) that underlie the results reported in publications arising from this study will be available to researchers upon request, subject to appropriate ethical, data protection and institutional requirements
Time frame: Available following the publication of the study results
Access criteria: Available to researchers on request, subject to approal by the study team/institution and applicable ethical and data protection requirements
Start is estimated for Nov 2026; primary completion for Jul 2028, 20 months later.
Of 89 non-industry interventional studies with no phase under Consciousness Disorders, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 52. This study's planned 20 months is close to that.
Counting every sponsor, half of 94 studies reached it within 19 months; a quarter within 8 and three quarters within 52.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Nov 9, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Prucalopride