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

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”

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.

Intervention(s) in this Clinical Trial

• Drug: quetiapine fumarate
  • flexible dose oral
• Drug: risperidone
  • flexible dose oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Quetiapine fumarate
• Active Comparator: 2
  • Risperidone

Primary Measures

• 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
  • Time Frame: Randomization to Month 24
    Safety Issue?: No
• 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
  • Time Frame: Randomization to Month 24
    Safety Issue?: No
• 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
  • Time Frame: Randomization to Month 24
    Safety Issue?: No

Secondary Measures

• Change in the Positive and Negative Syndrome Scale (PANSS) Total Score
  • Time Frame: Randomization to Month 24
    Safety Issue?: No
• Change in the PANSS Positive Subscale Score
  • Time Frame: Randomization to Month 24
    Safety Issue?: No
• Change in the PANSS Negative Subscale Score
  • Time Frame: Randomization to Month 24
    Safety Issue?: No
• Change in the PANSS Psychopathology Subscale Score
  • Time Frame: Randomization to Month 24
    Safety Issue?: No
• Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score
  • Time Frame: Randomization to Month 24
    Safety Issue?: No
• 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
  • Time Frame: Randomization to Month 24
    Safety Issue?: No
• Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score
  • Time Frame: Randomization to Month 24
    Safety Issue?: No
• Number of Relapses of Schizophrenia or Schizoaffective Disorder
  • Time Frame: At Month 24
    Safety Issue?: No
• Change in Simpson-Angus Scale (SAS) Total Score
  • Time Frame: Randomization to Month 24
    Safety Issue?: No
• Change in Barnes Akathisia Rating Scale (BARS) Global Score
  • Time Frame: Randomization to Month 24
    Safety Issue?: No
• Change in Abnormal Involuntary Movement Scale (AIMS) Total Score
  • Time Frame: Randomization to Month 24
    Safety Issue?: No
• Number of Participants With Potential Extrapyramidal Symptoms (EPS)
  • Time Frame: From start of the study treatment to last dose plus 30 days
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

AstraZeneca Seroquel Medical Science Director, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00206102

Study ID Number: 5077IL/0089

ClinicalTrials.gov Identifier: NCT00206102

Health Authority: United States: Food and Drug Administration