We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Risperidone Drug: Paliperidone Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Contrasting the Brain Effects of Risperidone and Invega With fMRI and PET Scanning
Study Start Date : July 2009
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Risperdal
Risperdal 2-8mg per day
 Drug: Risperidone
2mg - 8mg per day, for the duration of participation in the study
Other Name: Risperdal
Experimental: Invega
Invega 6-12mg per day
 Drug: Paliperidone
6mg - 12mg per day, for the duration of participation in the study
Other Name: Invega


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937261


Contacts
Layout table for location contacts
Contact: Liv McMillan, B.S. 949-824-3770 liv@uci.edu
Contact: Steven G Potkin, M.D. 714-456-5697 sgpotkin@uci.edu

Locations
Layout table for location information
United States, California
UC Irvine Recruiting
Irvine, California, United States, 92697
Contact: Steven G Potkin, M.D.    949-824-8040    sgpotkin@uci.edu   
Contact: Liv McMillan, B.S.    949-824-3770    liv@uci.edu   
Principal Investigator: Steven G Potkin, M.D.         
Sponsors and Collaborators
University of California, Irvine
Janssen, LP
Investigators
Layout table for investigator information
Principal Investigator: Steven G Potkin, M.D. UC Irvine
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Steven G. Potkin, M.D., UC Irvine -FBIRN
ClinicalTrials.gov Identifier: NCT00937261    
Other Study ID Numbers: BIRN 2008-6382
First Posted: July 10, 2009    Key Record Dates
Last Update Posted: October 28, 2010
Last Verified: October 2010
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Paliperidone Palmitate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Serotonin 5-HT2 Receptor Antagonists
Dopamine D2 Receptor Antagonists