The effect of SEP-363856 on brain dopamine synthesis capacity
Research type
Research Study
Full title
An Open-Label Positron Emission Tomography Study to Investigate the Effect of Adjunctive Administration of SEP-363856 on Brain Dopamine Synthesis Capacity Using 18F-DOPA in Adult Subjects With Schizophrenia
IRAS ID
262723
Contact name
Oliver Howes
Contact email
Sponsor organisation
Sunovion Pharmaceutical Inc.
Eudract number
2019-000568-65
Duration of Study in the UK
2 years, 7 months, days
Research summary
Summary of Research
The study medicine (SEP-363856) is an experimental treatment for schizophrenia: a condition that affects people’s thoughts, feelings and behaviour. It’s thought that high levels of a chemical messenger in the brain, called dopamine, contribute to the symptoms of schizophrenia. The study will look at whether the study medicine can help reduce the levels of dopamine levels. We’ll ask the patients to keep taking your current medicine for schizophrenia during this study.\n\nWe’ll test repeated doses of study medicine in up to 22 patients with schizophrenia, to see if the study medicine reduces dopamine levels in the brain. We’ll also measure blood levels of the study medicine, whether it has any side effects when given with patients’ regular antipsychotic(s), or has any effects on memory, or how patients think or feel.\n\nPatients will take a daily dose of up to 75 mg by mouth for 14 days, and have 3 types of brain scans: 1 MRI (magnetic resonance imaging) scan; and 2 PET-MR (positron emission tomography combined with fMRI (functional MRI)) scans. \n\nBefore each PET-MR scan, we’ll give patients an injection of a radioactive tracer (fluorine 18-DOPA). The PET-MR scan shows where the tracer is allowing us to measure the dopamine levels.\nAs part of the PET-MR scans, patients will be exposed to radiation similar to 5 years’ background radiation. \n\nPatients will take up to 8 weeks to finish the study. They will have up to 3 screening visits, one outpatient visit and 16 nights stay on the ward.\n\nA pharmaceutical company, Sunovion Pharmaceuticals Inc., is funding this study (Study SEP361-118).\n\nThe study will take place at 1 centre in London. Some of the screening visits and the brain scan visits will be done at 2 separate centres in London.Summary of Results
A lay summary of results will be posted to ClinicalTrials.gov.REC name
HSC REC B
REC reference
19/NI/0098
Date of REC Opinion
17 Jun 2019
REC opinion
Further Information Favourable Opinion