A D2 Receptor Occupancy and fMRI Study in Schizophrenic Subjects Treated With Lurasidone

Launched by UNIVERSITY OF CALIFORNIA, IRVINE · Nov 1, 2013

Keywords

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Gender

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Eligibility criteria

• 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.