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

Condition(s) targeted: Schizophrenia; Schizoaffective Disorder

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

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

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

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.

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 Participants With Schizophrenia or Schizoaffective Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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 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 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

Secondary outcome:

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

Change in the PANSS Positive Subscale Score

Change in the PANSS Negative Subscale Score

Change in the PANSS Psychopathology Subscale Score

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

Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q SF) Total Score

Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score

Number of Relapses of Schizophrenia or Schizoaffective Disorder

Change in Simpson-Angus Scale (SAS) Total Score

Change in Barnes Akathisia Rating Scale (BARS) Global Score

Change in Abnormal Involuntary Movement Scale (AIMS) Total Score

Number of Participants With Potential Extrapyramidal Symptoms (EPS)

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

Research Site, Little Rock, Arkansas, United States

Research Site, Mabelvale, Arkansas, United States

Research Site, Morrilton, Arkansas, United States

Research Site, Anaheim, 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, Long Beach, California, United States

Research Site, Los Angeles, California, United States

Research Site, Orange, California, United States

Research Site, San Diego, California, United States

Research Site, San Marcos, California, United States

Research Site, Denver, Colorado, United States

Research Site, New Britian, Connecticut, 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, Ft Lauderdale, Florida, United States

Research Site, Orlando, Florida, United States

Research Site, Pompano Beach, Florida, United States

Research Site, Tampa, Florida, United States

Research Site, W. Palm 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, Chicago, Illinois, United States

Research Site, Joliet, Illinois, United States

Research Site, Oak Brook Terrace, Illinois, United States

Research Site, Schaumburg, Illinois, United States

Research Site, Newton, Kansas, United States

Research Site, Wichita, 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, Brooklyn, New York, United States

Research Site, New York, New York, United States

Research Site, Staten Island, New York, United States

Research Site, Beechwood, Ohio, United States

Research Site, Cincinnati, Ohio, United States

Research Site, Dayton, Ohio, United States

Research Site, Lyndhurst, Ohio, United States

Research Site, Medina, Ohio, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Portland, Oregon, United States

Research Site, Media, Pennsylvania, United States

Research Site, Philadelphia, Pennsylvania, United States

Research Site, Charleston, South Carolina, United States

Research Site, Austin, Texas, United States

Research Site, Dallas, Texas, United States

Research Site, Houston, Texas, United States

Research Site, Irving, Texas, United States

Research Site, McKinney, Texas, United States

Research Site, San Antonio, Texas, United States

Research Site, Midvale, Utah, United States

Research Site, Arlington, Virginia, United States

Research Site, Falls Church, Virginia, United States

Research Site, Richmond, Virginia, United States

Starting date: September 2003
Last updated: January 8, 2013