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Contrasting the Brain Effects of Risperidone and Invega With Functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) Scanning

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ClinicalTrials.gov Identifier: NCT00937261
Recruitment Status : Unknown
Verified October 2010 by University of California, Irvine.
Recruitment status was:  Recruiting
First Posted : July 10, 2009
Last Update Posted : October 28, 2010
Sponsor:
Collaborator:
Janssen, LP
Information provided by:
University of California, Irvine

Tracking Information
First Submitted Date  ICMJE July 7, 2009
First Posted Date  ICMJE July 10, 2009
Last Update Posted Date October 28, 2010
Study Start Date  ICMJE July 2009
Estimated Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00937261 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Contrasting the Brain Effects of Risperidone and Invega With Functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) Scanning
Official Title  ICMJE Contrasting the Brain Effects of Risperidone and Invega With fMRI and PET Scanning
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Risperidone
    2mg - 8mg per day, for the duration of participation in the study
    Other Name: Risperdal
  • Drug: Paliperidone
    6mg - 12mg per day, for the duration of participation in the study
    Other Name: Invega
Study Arms  ICMJE
  • Experimental: Risperdal
    Risperdal 2-8mg per day
    Intervention: Drug: Risperidone
  • Experimental: Invega
    Invega 6-12mg per day
    Intervention: Drug: Paliperidone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 8, 2009)
96
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2011
Estimated Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00937261
Other Study ID Numbers  ICMJE BIRN 2008-6382
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven G. Potkin, M.D., UC Irvine -FBIRN
Study Sponsor  ICMJE University of California, Irvine
Collaborators  ICMJE Janssen, LP
Investigators  ICMJE
Principal Investigator: Steven G Potkin, M.D. UC Irvine
PRS Account University of California, Irvine
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP