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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University of California, Irvine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Janssen, LP
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00937261
First received: July 7, 2009
Last updated: October 27, 2010
Last verified: October 2010
History of Changes
  Purpose

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 Intervention Phase
Schizophrenia
 Drug: Risperidone
Drug: Paliperidone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Contrasting the Brain Effects of Risperidone and Invega With fMRI and PET Scanning

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: July 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937261

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

No publications provided

Responsible Party: Steven G. Potkin, M.D., UC Irvine -FBIRN
ClinicalTrials.gov Identifier: NCT00937261     History of Changes
Other Study ID Numbers: BIRN 2008-6382
Study First Received: July 7, 2009
Last Updated: October 27, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
9-hydroxy-risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 23, 2013