Schizophrenia Clinical Trial
Official title:
A D2 Receptor Occupancy and fMRI Study in Schizophrenic Subjects Treated With Lurasidone
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: Subjects are eligible to participate in this study if they: - are 18 to 60 years of age at the day of first dosing. - are diagnosed with schizophrenia or schizoaffective disorder. - are female, subject must be using an acceptable method of birth control or be surgically sterile or postmenopausal. Postmenopausal is defined as no period for at least 12 months. Acceptable methods of birth control include oral, injectable or implanted contraceptives, and barrier methods such as condoms, diaphrams, and spermicides. - are able to provide written informed consent. - can safety have an MRI (no metal in the body, not claustrophobic). Exclusion Criteria: Subjects are not eligible to participate in this study if they: - are treatment resisitant or intolerant to lurasidone. - have had extensive radiation exposure (the study doctor will discuss this with the subject). - if they have tremors or shaking of the limbs. - are pregnant or trying to become pregnant or breastfeeding. - are colorblind. - have a current or past history of a major medical illness or have abnormal lab values which the study doctor feels is significant (any abnormal lab values will be discussed with the subject). - are taking certain medications. The study doctor will discuss these medicines with the subject. - have a history of alcohol, cannabis or cocaine abuse within two weeks prior to the study. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UCI Medical Center | Orange | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Irvine | Dainippon Sumitomo Pharma America |
United States,
Potkin SG, Keator DB, Kesler-West ML, Nguyen DD, van Erp TG, Mukherjee J, Shah N, Preda A. D2 receptor occupancy following lurasidone treatment in patients with schizophrenia or schizoaffective disorder. CNS Spectr. 2014 Apr;19(2):176-81. doi: 10.1017/S10 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | D2 receptor occupancy | To determine whether additional D2 receptor occupancy can be accomplished with doses of 160 mg of lurasidone per day. | Up to 6 weeks | No |
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