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

University of California Irvine (UCI)

Status and phase: Unknown; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Risperidone; Drug: Paliperidone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00937261

BIRN 2008-6382

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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96 participants in 2 patient groups

Risperdal

Experimental group

Description:

Risperdal 2-8mg per day

Treatment:

Drug: Risperidone

Invega

Experimental group

Description:

Invega 6-12mg per day

Treatment:

Drug: Paliperidone