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

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Drug: quetiapine fumarate; Drug: risperidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00206102

D1441C00089

5077IL/0089

Details and patient eligibility

About

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.

Enrollment: 1,098 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,098 participants in 2 patient groups

1

Experimental group

Description:

Quetiapine fumarate

Treatment:

Drug: quetiapine fumarate

2

Active Comparator group

Description:

Risperidone

Treatment:

Drug: risperidone