PROMOTE: Effects of 5-HT4 Agonism on Cognition and Sleep in Peopl With Low Mood
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Oxford
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Prucalopride
DrugPrucalopride 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.
Placebo Comparator
DrugA 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: PrucaloprideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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 intervention2
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)3
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)4
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)Other outcomes
1
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.2
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.3
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 intervention4
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 interventionSponsors and contacts
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Source ClinicalTrials.gov
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