Clinical trial NCT03572790: Effects of Seven Day Prucalopride Administration in Healthy Volunteers
Official title: The Effect of Seven Day Prucalopride Administration on Emotional Processing in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Molecular Mechanisms of Pharmacological Action
Depression
Depressive Disorder
Mood Disorders
Mental Disorders
Antidepressive Agents
Cognition
Keywords: 5-HT4
Prucalopride
Resolor
Functional Magnetic Resonance Imaging (fMRI)
Emotional Processing
Healthy Volunteers
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated to one of two groups (prucalopride or placebo). Participants in the prucalopride group will receive 1mg once daily for seven days. Participants in the placebo group will receive a lactose placebo once daily for seven days. Note that the study is not assessing the safety or efficacy of prucalopride, rather it is using prucalopride to assess the behavioural and neural effects of 5-HT4 partial agonists.
Primary purpose: BASIC_SCIENCE

Brief summary: This study will investigate whether seven days administration of the serotonin receptor subtype 4 (5-HT4) partial agonist prucalopride has effects on emotional processing and neural activity in healthy volunteers, compared to placebo administration. Using an experimental medicine approach, the effects of prucalopride on cognitive biomarkers of antidepressant action will be characterised. In a double-blind design, participants will be randomised to receive seven days administration of either prucalopride (1mg daily) or placebo. All participants will come for a Screening visit, Research Visit One (including an MRI scan) and Research Visit Two (including measures of emotional processing and non-emotional cognition). The primary study hypothesis is that seven-day prucalopride administration will have positive effects on emotional processing and reward sensitivity. A secondary hypothesis is that seven-day prucalopride administration will alter non-emotional cognition. Finally, the study will test the hypothesis that seven day prucalopride administration will alter neural activity during an emotional faces task and a memory task.


Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study
* Male or female
* Aged 18-40 years
* Sufficiently fluent English to understand and complete the task
* Right handed
* Body Mass Index in the range of 18-30
* Not currently taking any medications (except the contraceptive pill)

Exclusion Criteria:

* Not fluent in English
* Any past or current Axis 1 DSM-V psychiatric disorder
* Current usage of psychoactive medication (except the contraceptive pill, the Depo-Provera injection or the progesterone implant)
* Current usage of any medication that will influence the MRI scan
* Current or past history of drug or alcohol dependency
* Currently pregnant or breastfeeding
* Study visits due to take place during the pre-menstrual week (female participants asked details of their menstrual cycle to schedule the study outside this week)
* Not right handed
* Body Mass Index outside the range of 18-30
* History of cardiac, thyroid, or liver problems
* An autoimmune disorder
* Current, or a history of, gastro-intestinal disorder or irritable bowel syndrome
* Epilepsy
* Known lactate deficiency or any other problem absorbing lactose, galactose, or glucose
* Participation in a study which uses the same computer tasks as those used in the present study
* Participation in a study that involves the use of a medication within the last three months
* Smoker \> 5 cigarettes per day
* Typically drinks \> 6 caffeinated drinks per day
* Any contraindication to MRI scanning (e.g. metal objects in the body, pacemakers, significant claustrophobia)

Primary outcomes:
measure: Recognition of positive and negative facial expressions
timeFrame: Completed on Day 7
measure: Performance on Auditory Verbal Learning Task (AVLT)
timeFrame: Completed on Day 7
Secondary outcomes:
measure: Neural response to emotional faces
timeFrame: Completed on Day 6
measure: Neural response to novel vs repeated scenes
timeFrame: Completed on Day 6
measure: Reward sensitivity
timeFrame: Completed on Day 7
measure: Categorisation, recall, and recognition of emotional words
timeFrame: Completed on Day 7
measure: Vigilance to fearful and happy faces on the Facial Dot Probe Task (FDOT)
timeFrame: Completed on Day 7
measure: Resting state connectivity
timeFrame: Completed on Day 6
measure: Relative and global cerebral blood flow
timeFrame: Completed on Day 6
measure: Visual short term memory on the Oxford Memory Test (OMT)
timeFrame: Completed on Day 7
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: University of Oxford
Study officials:
affiliation: University of Oxford
name: Susannah E Murphy, DPhil
role: PRINCIPAL_INVESTIGATOR
References: