Clinical trial: A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder

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Seroquel Risperdal Consta Risperdal

A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder

Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizoaffective; Schizophrenic Disorder

Intervention: quetiapine fumarate (Drug); risperidone (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Seroquel Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

Summary

This Phase IV, randomized, parallel-group study is designed to evaluate the cataractogenic potential of quetiapine fumarate (SEROQUEL™) compared with that of a putative non-cataractogenic antipsychotic medication risperidone (RISPERDAL™). This study is being conducted to fulfill the SEROQUEL Phase IV commitment regarding evaluation of cataractogenic potential.

Clinical Details

Official title: A Multicenter, Open Label, Flexible-Dose, Parallel-Group Evaluation of the Cataractogenic Potential of Quetiapine Fumarate (Seroquel™ ) and Risperidone (Risperdal™ ) in the Long Term Treatment of Patients With Schizophrenia or Schizoaffective Disorder

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Presence/absence of cataractogenic events in patients with 2 years of exposure

Secondary outcome:

Extrapyramidal symptoms
Adverse events
Serious adverse events
Withdrawals

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:
- Men and women age 18 to 65

- Both Eyes present with lenses intact (no previous cataract extractions)

- Stable place of residency
Exclusion Criteria:
- History of corneal surgery

- Legal blindness (defined as best corrected visual acuity of 20/200 or worse in one or
both eyes
- Previous participation in this study

Locations and Contacts

Research Site, Little Rock, Arkansas, United States
Research Site, Mabelvale, Arkansas, United States
Research Site, Morrilton, Arkansas, United States
Research Site, San Diego, California, United States
Research Site, Long Beach, California, United States
Research Site, Orange, California, United States
Research Site, Anaheim, California, United States
Research Site, San Marcos, California, United States
Research Site, Los Angeles, California, United States
Research Site, Cerritos, California, United States
Research Site, Chula Vista, California, United States
Research Site, Garden Grove, California, United States
Research Site, Denver, Colorado, United States
Research Site, New Britian, Connecticut, United States
Research Site, W. Palm Beach, Florida, United States
Research Site, Ft Lauderdale, Florida, United States
Research Site, Tampa, Florida, United States
Research Site, Boca Raton, Florida, United States
Research Site, Boynton Beach, Florida, United States
Research Site, Deerfield Beach, Florida, United States
Research Site, Orlando, Florida, United States
Research Site, Pompano Beach, Florida, United States
Research Site, West Palm Beach, Florida, United States
Research Site, Atlanta, Georgia, United States
Research Site, Augusta, Georgia, United States
Research Site, Schaumburg, Illinois, United States
Research Site, Chicago, Illinois, United States
Research Site, Oak Brook Terrace, Illinois, United States
Research Site, Joliet, Illinois, United States
Research Site, Wichita, Kansas, United States
Research Site, Newton, Kansas, United States
Research Site, Metairie, Louisiana, United States
Research Site, New Orleans, Louisiana, United States
Research Site, Glen Burnie, Maryland, United States
Research Site, Minneapolis, Minnesota, United States
Research Site, St. Louis, Missouri, United States
Research Site, Las Vegas, Nevada, United States
Research Site, Cherry Hill, New Jersey, United States
Research Site, Moorestown, New Jersey, United States
Research Site, Paramus, New Jersey, United States
Research Site, Stratford, New Jersey, United States
Research Site, New York, New York, United States
Research Site, Staten Island, New York, United States
Research Site, Brooklyn, New York, United States
Research Site, Cincinnati, Ohio, United States
Research Site, Beechwood, Ohio, United States
Research Site, Dayton, Ohio, United States
Research Site, Medina, Ohio, United States
Research Site, Lyndhurst, Ohio, United States
Research Site, Oklahoma City, Oklahoma, United States
Research Site, Portland, Oregon, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Media, Pennsylvania, United States
Research Site, Charleston, South Carolina, United States
Research Site, Austin, Texas, United States
Research Site, Dallas, Texas, United States
Research Site, Irving, Texas, United States
Research Site, San Antonio, Texas, United States
Research Site, Houston, Texas, United States
Research Site, McKinney, Texas, United States
Research Site, Midvale, Utah, United States
Research Site, Falls Church, Virginia, United States
Research Site, Arlington, Virginia, United States
Research Site, Richmond, Virginia, United States

Additional Information

Starting date: September 2003
Ending date: December 2008
Last updated: January 11, 2008

Page last updated: June 20, 2008

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