NCT00937261UnknownPhase 4
Contrasting the Brain Effects of Risperidone and Invega With fMRI and PET Scanning
University of California, Irvine1 site in 1 country96 target enrollmentStarted: July 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Comparison of BOLD signal activation and FDG metabolism of the DLPFC, superior temporal gyrus and amygdala, and their interaction between Invega and Risperdal
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- 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.
Arms & Interventions
Risperdal
Experimental
Risperdal 2-8mg per day
Intervention: Risperidone (Drug)
Invega
Experimental
Invega 6-12mg per day
Intervention: Paliperidone (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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