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

NCT00206102 | Completed Phase 4 Results

• 2 other identifiers: 5077IL/0089D1441C00089
• Study Type: interventional
• Target: 1,098
• Locations: 1 country
• Sites: 63

Brief 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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (3)

• Presence of a Cortical (C) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the Lens Opacities Classification System II (LOCS II ) Grading Scale

  Presence of C type of cataractogenic potential event in participant was defined if any LOCS II grades of 2, 3, 4, 5 (with any grade of 0, trace,1 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0= no cataract; 5 is worst. There are no subscales. 0 is the best, 5 is the worst.

  Randomization to Month 24

• Presence of a Nuclear Opalescence (N) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale

  Presence of N type of cataractogenic potential event in Participants was defined if any LOCS II grades of 2, 3, 4 (with grade at rand equals 0,1), or if the LOCS II grades of 3,or 4 (with grade at randomization=2) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst.

  Randomization to Month 24

• Presence of a Posterior Subcapsular (P) Type Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale

  Presence of P type of cataractogenic potential event in participant was defined if any LOCS II grades of 1, 2, 3 , 4 (with grade=0 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst.

  Randomization to Month 24

Secondary Outcomes (12)

• Change in the Positive and Negative Syndrome Scale (PANSS) Total Score

  Randomization to Month 24

• Change in the PANSS Positive Subscale Score

  Randomization to Month 24

• Change in the PANSS Negative Subscale Score

  Randomization to Month 24

• Change in the PANSS Psychopathology Subscale Score

  Randomization to Month 24

• Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score

  Randomization to Month 24

Study Arms (2)

1

EXPERIMENTAL

Quetiapine fumarate

Drug: quetiapine fumarate

2

ACTIVE COMPARATOR

Risperidone

Drug: risperidone

Interventions

quetiapine fumarate DRUG

flexible dose oral

Also known as: Seroquel, ICI 204,636

1

risperidone DRUG

flexible dose oral

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women age 18 to 65
• Both Eyes present with lenses intact (no previous cataract extractions)
• Stable place of residency

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (63)

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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MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Quetiapine Fumarate; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

AZTrial_Results_Posting@astrazeneca.com

Study Officials

• AstraZeneca Seroquel Medical Science Director, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 21, 2005
• Study Start: September 1, 2003
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: January 14, 2013
• Results First Posted: July 13, 2011

Record last verified: 2013-01

Locations

US (63)