Healthy volunteer community population with psychotic-like experiences in the last 12 months Mental and Behavioural Disorders
Conditions
Interventions
Intervention arm: Prucalopride (tablets, over-encapsulated in a vegetarian shell and filled with Lactose Monohydrate Ph. Eur. powder or equivalent grade) 1mg for 2 days and then 2x1mg for 5-8 days (ma
Bottle 2 contains medication for day 3 onwards. A researcher will contact participants by prior agreement on day 2 to confirm that participants have not had side effects and to move from Bottle 1 to B
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-40 years inclusive 2. Consent to the study 3. Recent psychotic-like experiences (last 12 months) 4. Fluent in English
Exclusion criteria
Exclusion criteria: 1. Current antipsychotic medication 2. Current antidepressant medication 3. Documented history of intellectual disability 4. Past or current clinically relevant central nervous system disorder 5. Current significant medical disorder 6. Current or past treated or untreated psychotic episode 7. Pregnancy, breastfeeding, or actively trying to become pregnant. Participants will be asked to avoid becoming pregnant. 8. Individuals with contraindications for MRI, including those with non-MRI-safe metallic or electronic implants, incompatible medical devices, severe claustrophobia, or exceeding scanner size limits 9. Recent (in the last 3 months) involvement in a study that uses an experimental drug or device 10. Recent (in the last 6 months) involvement in a study using similar thinking or emotional tasks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pattern of effect across a battery of behavioural neurocognitive measures: the auditory verbal learning task (AVLT), working memory task (N-back), facial expression recognition task (FERT), rewards learning task (PILT) from enrollment to the end of the study (after 7-10 days of medication) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed at baseline and follow-up, from enrolment to the end of the study (after 7–10 days of medication), unless otherwise stated: 1. Changes in brain network connectivity measured using resting-state functional MRI 2. Brain metabolites, such as choline and glutamate/glutamine, levels in the hippocampus are measured using magnetic resonance spectroscopy (MRS) 3. Blood biomarkers linked to psychotic symptoms and 5-HT4 agonism (IL-1b, IL-6, IL-10, TNFa, IFNg, BDNF, S100B and SuPAR) and prucalopride levels measured using blood tests from enrolment to the end of the study (after 7–10 days of medication). Biomarkers in blood will be quantified by multiplex analysis (Luminex) and ELISA. Prucalopride in the blood will be quantified by chromatography and mass spectrometry. 4. Subjective cognition measured using self-report measures (PDQ-20 (Perceived Deficits Questionnaire)) | — |
Countries
England, United Kingdom
Contacts
Public ContactAngharad de Cates
Outcome results
None listed