Contrasting the Brain Effects of Risperidone and Invega With Functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) Scanning
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 schizophrenia
Started Jul 2009
Shorter than P25 for phase_4 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 7, 2009
CompletedFirst Posted
Study publicly available on registry
July 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedOctober 28, 2010
October 1, 2010
1 year
July 7, 2009
October 27, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of BOLD signal activation and FDG metabolism of the DLPFC, superior temporal gyrus and amygdala, and their interaction between Invega and Risperdal
approximately 6-10 weeks
Study Arms (2)
Risperdal
EXPERIMENTALRisperdal 2-8mg per day
Invega
EXPERIMENTALInvega 6-12mg per day
Interventions
2mg - 8mg per day, for the duration of participation in the study
6mg - 12mg per day, for the duration of participation in the study
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Irvinelead
- Janssen, LPcollaborator
Study Sites (1)
UC Irvine
Irvine, California, 92697, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven G Potkin, M.D.
UC Irvine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 7, 2009
First Posted
July 10, 2009
Study Start
July 1, 2009
Primary Completion
July 1, 2010
Study Completion
January 1, 2011
Last Updated
October 28, 2010
Record last verified: 2010-10