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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
Janssen, LP
Information provided by:
University of California, Irvine Identifier:
First received: July 7, 2009
Last updated: October 27, 2010
Last verified: October 2010

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
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:

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


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00937261

Contact: Liv McMillan, B.S. 949-824-3770
Contact: Steven G Potkin, M.D. 714-456-5697

United States, California
UC Irvine Recruiting
Irvine, California, United States, 92697
Contact: Steven G Potkin, M.D.    949-824-8040   
Contact: Liv McMillan, B.S.    949-824-3770   
Principal Investigator: Steven G Potkin, M.D.         
Sponsors and Collaborators
University of California, Irvine
Janssen, LP
Principal Investigator: Steven G Potkin, M.D. UC Irvine
  More Information

No publications provided

Responsible Party: Steven G. Potkin, M.D., UC Irvine -FBIRN 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:
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents processed this record on November 20, 2014