Contrasting the Brain Effects of Risperidone and Invega With Functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) Scanning
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...
Brief Summary
Official Title: “Contrasting the Brain Effects of Risperidone and Invega With fMRI and PET Scanning”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: July 2010
Intervention(s) in this Clinical Trial
- Drug: Risperidone
- 2mg - 8mg per day, for the duration of participation in the study
- Drug: Paliperidone
- 6mg - 12mg per day, for the duration of participation in the study
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Risperdal
- Risperdal 2-8mg per day
- Experimental: Invega
- Invega 6-12mg per day
Outcome Measures for this Clinical Trial
Primary Measures
- 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
Safety Issue?: No
- Time Frame: approximately 6-10 weeks
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 60 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: University of California, Irvine Other
Overall Clinical Trial Officials and Contacts
Steven G Potkin, M.D. Principal Investigator UC Irvine
Overall Contact: Liv McMillan, B.S. 949-824-3770 liv@uci.edu
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00937261
Study ID Number: BIRN 2008-6382
ClinicalTrials.gov Identifier: NCT00937261
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00937261
