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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


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


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


Inclusion Criteria:

- are currently taking Risperdal and have been on the medication for at least three


- 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

Page last updated: August 23, 2015

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