A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Patients 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...

Date First Received: September 14, 2005

Last Updated: January 11, 2008

Verified by: AstraZeneca, January 2008

Clinical Trial Phase: Phase 4 | Start Date: September 2003

Overall Status: Active, not recruiting

Estimated Enrollment: 1099

Brief Summary

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”

Condition Keyword(s):

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.

Study Type: Interventional

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

Study Primary Completion Date: November 2008

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

Outcome Measures for this Clinical Trial

Primary Measures

  • Presence/absence of cataractogenic events in patients with 2 years of exposure

Secondary Measures

  • Extrapyramidal symptoms
  • Adverse events
  • Serious adverse events
  • Withdrawals

Criteria for Participation in this Clinical Trial

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

Clinical Trial Sponsor Information

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

AstraZeneca Seroquel Medical Science Director, MD Study Director AstraZeneca  

Additional Information

Information obtained from ClinicalTrials.gov on December 03, 2008

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

Study ID Number: D1441C00089

ClinicalTrials.gov Identifier: NCT00206102

Health Authority: United States: Food and Drug Administration

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