Contrasting the Brain Effects of Risperidone and Invega With Functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) Scanning
Information source: University of California, Irvine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Risperidone (Drug); Paliperidone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of California, Irvine Official(s) and/or principal investigator(s): Steven G Potkin, M.D., Principal Investigator, Affiliation: UC Irvine
Overall contact: Liv McMillan, B.S., Phone: 949-824-3770, Email: liv@uci.edu
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.
Clinical Details
Official title: Contrasting the Brain Effects of Risperidone and Invega With fMRI and PET Scanning
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Comparison of BOLD signal activation and FDG metabolism of the DLPFC, superior temporal gyrus and amygdala, and their interaction between Invega and Risperdal
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
Liv McMillan, B.S., Phone: 949-824-3770, Email: liv@uci.edu
UC Irvine, Irvine, California 92697, United States; Recruiting Steven G Potkin, M.D., Phone: 949-824-8040, Email: sgpotkin@uci.edu Liv McMillan, B.S., Phone: 949-824-3770, Email: liv@uci.edu Steven G Potkin, M.D., Principal Investigator
Additional Information
Starting date: July 2009
Last updated: October 27, 2010
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