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

NCT ID: NCT00206102

Last Updated: 2013-01-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1098 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Quetiapine fumarate

Group Type EXPERIMENTAL

quetiapine fumarate

Intervention Type DRUG

flexible dose oral

2

Risperidone

Group Type ACTIVE_COMPARATOR

risperidone

Intervention Type DRUG

flexible dose oral

Interventions

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quetiapine fumarate

flexible dose oral

Intervention Type DRUG

risperidone

flexible dose oral

Intervention Type DRUG

Other Intervention Names

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Seroquel ICI 204,636

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AstraZeneca Seroquel Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Little Rock, Arkansas, United States

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Mabelvale, Arkansas, United States

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Morrilton, Arkansas, United States

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Anaheim, California, United States

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Cerritos, California, United States

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Chula Vista, California, United States

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Garden Grove, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Orange, California, United States

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San Diego, California, United States

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San Marcos, California, United States

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Denver, Colorado, United States

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New Britian, Connecticut, United States

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Boca Raton, Florida, United States

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Boynton Beach, Florida, United States

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Deerfield Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Orlando, Florida, United States

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Pompano Beach, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Chicago, Illinois, United States

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Joliet, Illinois, United States

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Oak Brook Terrace, Illinois, United States

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Schaumburg, Illinois, United States

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Newton, Kansas, United States

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Wichita, Kansas, United States

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Metairie, Louisiana, United States

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New Orleans, Louisiana, United States

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Glen Burnie, Maryland, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Cherry Hill, New Jersey, United States

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Moorestown, New Jersey, United States

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Paramus, New Jersey, United States

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Stratford, New Jersey, United States

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Brooklyn, New York, United States

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New York, New York, United States

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Staten Island, New York, United States

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Beechwood, Ohio, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Lyndhurst, Ohio, United States

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Medina, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Media, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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McKinney, Texas, United States

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San Antonio, Texas, United States

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Midvale, Utah, United States

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Arlington, Virginia, United States

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Falls Church, Virginia, United States

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Richmond, Virginia, United States

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Countries

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United States

Other Identifiers

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D1441C00089

Identifier Type: -

Identifier Source: secondary_id

5077IL/0089

Identifier Type: -

Identifier Source: org_study_id

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