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

This study has been completed.

First Received: September 14, 2005 Last Updated: August 25, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00206102

Purpose

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.

Condition	Intervention	Phase
Schizoaffective Schizophrenic Disorder	Drug: quetiapine fumarate Drug: risperidone	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Extrapyramidal symptoms
Adverse events
Serious adverse events
Withdrawals

Enrollment:	1099
Study Start Date:	September 2003
Study Completion Date:	October 2008

Arms	Assigned Interventions
1: Experimental Quetiapine fumarate	Drug: quetiapine fumarate flexible dose oral
2: Active Comparator Risperidone	Drug: risperidone flexible dose oral

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206102

Show 64 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Seroquel Medical Science Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D1441C00089, 5077IL/0089
Study First Received:	September 14, 2005
Last Updated:	August 25, 2009
ClinicalTrials.gov Identifier:	NCT00206102 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

schizoaffective
schizophrenia disorder

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Risperidone
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions

Schizophrenia
Quetiapine
Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Mental Disorders
Therapeutic Uses
Dopamine Agents
Psychotic Disorders
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 08, 2010