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

NCT ID: NCT00937261

Last Updated: 2010-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Risperdal

Risperdal 2-8mg per day

Group Type EXPERIMENTAL

Risperidone

Intervention Type DRUG

2mg - 8mg per day, for the duration of participation in the study

Invega

Invega 6-12mg per day

Group Type EXPERIMENTAL

Paliperidone

Intervention Type DRUG

6mg - 12mg per day, for the duration of participation in the study

Interventions

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Risperidone

2mg - 8mg per day, for the duration of participation in the study

Intervention Type DRUG

Paliperidone

6mg - 12mg per day, for the duration of participation in the study

Intervention Type DRUG

Other Intervention Names

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Risperdal Invega

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen, LP

INDUSTRY

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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UC Irvine -FBIRN

Principal Investigators

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Steven G Potkin, M.D.

Role: PRINCIPAL_INVESTIGATOR

UC Irvine

Locations

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UC Irvine

Irvine, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Liv McMillan, B.S.

Role: CONTACT

Phone: 949-824-3770

Email: [email protected]

Steven G Potkin, M.D.

Role: CONTACT

Phone: 714-456-5697

Email: [email protected]

Facility Contacts

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Steven G Potkin, M.D.

Role: primary

Liv McMillan, B.S.

Role: backup

Other Identifiers

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BIRN 2008-6382

Identifier Type: -

Identifier Source: org_study_id