Recruiting

Risperidone vs. Invega

Sponsor:

UCLA

Code:

NCT00937261

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Risperidone

Paliperidone

Study Details

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.

Conditions

Schizophrenia

Study ID

NCT00937261

Start date

Jul, 2009

Status verified date

Oct, 2010

Completion date

Jan, 2011

Anticipated

Primary completion date

Jul, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Risperdal

Risperdal 2-8mg per day

experimental: Invega

Invega 6-12mg per day

Interventions

Risperidone

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

Paliperidone

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Liv McMillan, B.S.

949-824-3770liv@uci.edu

Steven G Potkin, M.D.

714-456-5697sgpotkin@uci.edu

Locations

UC Irvine

Recruiting

Irvine, California, United States, 92697

Contacts

Steven G Potkin, M.D.

949-824-8040sgpotkin@uci.edu

Liv McMillan, B.S.

949-824-3770liv@uci.edu

Principal Investigator:

Steven G Potkin, M.D.

More Information

Sponsor

University of California, Irvine

Last update posted

Oct 28, 2010

Last verified

Oct, 2010

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2010-10-28.