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

NCT01979679 | Completed Phase 3 DMC

• 1 other identifier: 2008-6481
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Lurasidone 80 mg per day

ACTIVE COMPARATOR

Lurasidone 80 mg per day

Drug: Lurasidone 80 mg

Lurasidone 120 mg per day

ACTIVE COMPARATOR

Lurasidone 120 mg per day

Drug: Lurasidone 120 mg

Lurasidone 160 mg per day

ACTIVE COMPARATOR

Lurasidone 160 mg per day

Drug: Lurasidone 160 mg

Interventions

Lurasidone 80 mg DRUG

Lurasidone 80 mg per day

Lurasidone 120 mg DRUG

Lurasidone 120 mg per day

Lurasidone 160 mg DRUG

Lurasidone 160 mg per day

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead
• Dainippon Sumitomo Pharma America: collaborator

Study Sites (1)

UCI Medical Center

Orange, California, 92868, United States

Location

Related Publications (1)

• 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.

  PMID: 24073841 RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Steven G Potkin, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2013
• First Posted: November 8, 2013
• Study Start: December 1, 2008
• Primary Completion: October 1, 2013
• Last Updated: November 8, 2013

Record last verified: 2013-11

Locations

US (1)