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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Lurasidone 80 mg; Drug: Lurasidone 120 mg; Drug: Lurasidone 160 mg

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • UCI Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lurasidone 80 mg per day	Drug: Lurasidone 80 mg
Active Comparator: Lurasidone 120 mg per day	Drug: Lurasidone 120 mg
Active Comparator: Lurasidone 160 mg per day	Drug: Lurasidone 160 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: Dainippon Sumitomo Pharma America
• Investigators: Principal Investigator: Steven G Potkin, MD, University of California, Irvine

Publications and helpful links

General Publications

• 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/S109285291300059X. Epub 2013 Sep 30.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): October 1, 2013
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: November 1, 2013
• First Submitted That Met QC Criteria: November 1, 2013
• First Posted (Estimate): November 8, 2013

Study Record Updates

• Last Update Posted (Estimate): November 8, 2013
• Last Update Submitted That Met QC Criteria: November 1, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Lurasidone Hydrochloride
• Other Study ID Numbers: 2008-6481

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No