Schizophrenia | Contrasting the Brain Effects of Risperidone and Invega With Functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) Scanning
Schizophrenia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Risperidone2mg - 8mg per day, for the duration of participation in the study
Drug:Paliperidone6mg - 12mg per day, for the duration of participation in the study
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
RisperdalRisperdal 2-8mg per day
InvegaInvega 6-12mg per day
Start Date: July 2009
Completed Date: January 2011
Phase: Phase 4
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
Study sponsors, principal investigator, and references
Principal Investigator: Steven G Potkin, M.D.
Lead Sponsor: University of California, Irvine
Collaborator: Janssen, LP