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

October 27, 2010 updated by: University of California, Irvine

Contrasting the Brain Effects of Risperidone and Invega With fMRI and PET Scanning

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92697
        • Recruiting
        • UC Irvine
        • Contact:
          • Liv McMillan, B.S.
          • Phone Number: 949-824-3770
          • Email: liv@uci.edu
        • Contact:
        • Principal Investigator:
          • Steven G Potkin, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • Risperdal
Experimental: Invega
Invega 6-12mg per day
Drug: Paliperidone
6mg - 12mg per day, for the duration of participation in the study
Other Names:
  • Invega

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
approximately 6-10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Janssen, LP

Investigators

  • Principal Investigator: Steven G Potkin, M.D., UC Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

July 1, 2010

Study Completion (Anticipated)

January 1, 2011

Study Registration Dates

First Submitted

July 7, 2009

First Submitted That Met QC Criteria

July 8, 2009

First Posted (Estimate)

July 10, 2009

Study Record Updates

Last Update Posted (Estimate)

October 28, 2010

Last Update Submitted That Met QC Criteria

October 27, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIRN 2008-6382

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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