Schizophrenia
Conditions
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.
Interventions
DRUGRisperidone
2mg - 8mg per day, for the duration of participation in the study
DRUGPaliperidone
6mg - 12mg per day, for the duration of participation in the study
Sponsors
Janssen, LP
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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.
Design outcomes
Primary
| 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 | approximately 6-10 weeks |
Countries
United States
Contacts
Primary ContactLiv McMillan, B.S.
Backup ContactSteven G Potkin, M.D.
Outcome results
None listed