Back to resultsContrasting the Brain Effects of Risperidone and Invega With Functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) Scanning
Primary Purpose
Schizophrenia
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Risperidone
Paliperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- are currently taking Risperdal and have been on the medication for at least three weeks
- are diagnosed with schizophrenia
- are able to provide written informed consent
- can safely have an MRI
Exclusion Criteria:
- are treatment resistant or intolerant to Risperdal
- have participated in another drug study in the past 28 days
- are pregnant or trying to become pregnant or are breastfeeding
- are colorblind
- have a history of alcohol, cannabis, or cocaine abuse within two weeks prior to the study
- have a current or past history of a major medical illness or have abnormal lab values which the study doctor feels is significant
- certain medications are also exclusionary including aripiprazole.
Sites / Locations
- UC IrvineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Risperdal
Invega
Arm Description
Risperdal 2-8mg per day
Invega 6-12mg per day
Outcomes
Primary Outcome Measures
Comparison of BOLD signal activation and FDG metabolism of the DLPFC, superior temporal gyrus and amygdala, and their interaction between Invega and Risperdal
Secondary Outcome Measures
Full Information
NCT ID
NCT00937261
First Posted
July 7, 2009
Last Updated
October 27, 2010
Sponsor
University of California, Irvine
Collaborators
Janssen, LP
1. Study Identification
Unique Protocol Identification Number
NCT00937261
Brief Title
Contrasting the Brain Effects of Risperidone and Invega With Functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) Scanning
Official Title
Contrasting the Brain Effects of Risperidone and Invega With fMRI and PET Scanning
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
January 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of California, Irvine
Collaborators
Janssen, LP
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to better understand brain function and psychiatric and neurological illness when taking Invega or Risperdal. The objective is to compare the brain effects of Invega to Risperdal in patients with Schizophrenia. This comparison will be evaluated with PET imaging, fMRI, and neurological ratings and assessments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Risperdal
Arm Type
Experimental
Arm Description
Risperdal 2-8mg per day
Arm Title
Invega
Arm Type
Experimental
Arm Description
Invega 6-12mg per day
Intervention Type
Drug
Intervention Name(s)
Risperidone
Other Intervention Name(s)
Risperdal
Intervention Description
2mg - 8mg per day, for the duration of participation in the study
Intervention Type
Drug
Intervention Name(s)
Paliperidone
Other Intervention Name(s)
Invega
Intervention Description
6mg - 12mg per day, for the duration of participation in the study
Primary Outcome Measure Information:
Title
Comparison of BOLD signal activation and FDG metabolism of the DLPFC, superior temporal gyrus and amygdala, and their interaction between Invega and Risperdal
Time Frame
approximately 6-10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
are currently taking Risperdal and have been on the medication for at least three weeks
are diagnosed with schizophrenia
are able to provide written informed consent
can safely have an MRI
Exclusion Criteria:
are treatment resistant or intolerant to Risperdal
have participated in another drug study in the past 28 days
are pregnant or trying to become pregnant or are breastfeeding
are colorblind
have a history of alcohol, cannabis, or cocaine abuse within two weeks prior to the study
have a current or past history of a major medical illness or have abnormal lab values which the study doctor feels is significant
certain medications are also exclusionary including aripiprazole.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liv McMillan, B.S.
Phone
949-824-3770
Email
liv@uci.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Steven G Potkin, M.D.
Phone
714-456-5697
Email
sgpotkin@uci.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven G Potkin, M.D.
Organizational Affiliation
UC Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven G Potkin, M.D.
Phone
949-824-8040
Email
sgpotkin@uci.edu
First Name & Middle Initial & Last Name & Degree
Liv McMillan, B.S.
Phone
949-824-3770
Email
liv@uci.edu
First Name & Middle Initial & Last Name & Degree
Steven G Potkin, M.D.
12. IPD Sharing Statement
Learn more about this trial
Contrasting the Brain Effects of Risperidone and Invega With Functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) Scanning
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