Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
AstraZeneca |
---|---|
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00206102 |
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 |
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
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | AstraZeneca Seroquel Medical Science Director, MD | AstraZeneca |
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 |
schizoaffective schizophrenia disorder |
Neurotransmitter Agents Tranquilizing Agents Risperidone Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Serotonin |
Schizophrenia Quetiapine Dopamine Mental Disorders Psychotic Disorders Dopamine Agents Schizophrenia and Disorders with Psychotic Features |
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 |