A D2 Receptor Occupancy and fMRI Study in Schizophrenic Subjects Treated With Lurasidone
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The purpose of this research study is to measure how many of the dopamine receptors
lurasidone occupies throughout the brain of patients with schizophrenia or schizoaffective
disorder and over what time period the occupancy occurs. This is research because lurasidone
is an investigational medication that has not yet been approved by the Food and Drug
Administration (FDA). Dopamine receptors have key roles in many processes, including the
control of motivation, learning, and fine motor movement. The degree of occupancy and the
transience of occupancy D2 receptor occupancy for optimal clinical response and to prevent
relapses is a controversial area that this study will address.
In this study Positron Emission Tomography (PET) scanning will be performed with D2/D3 ligand
18F-fallypride (a radioactive, injectable substance) to help the researchers measure the use
of these receptors. Researchers hope that quantifying the amount of receptors being occupied
by the medication will help them to determine the best dose of study medication in terms of
improvement and least side effects related to body size and gender as well as in preventing
relapse that may be related to hypersensitivity. Magnetic Resonance Imaging (fMRI) will also
be performed. MRI is a scanning method which makes pictures of parts of the brain using a
large magnetic field. This study will use a particular kind of MRI called fMRI, or functional
MRI. fMRI takes pictures of the brain while the person is thinking or doing a simple task.
fMRI will allow the researchers to investigate patients regional brain activation during
cognitive (mental) and emotional tasks.