Status:
COMPLETED
A Study Comparing Three Strategies to Switch Patients With Schizophrenia or Schizoaffective Disorder to Risperidone After Unsuccessful Treatment With Olanzapine.
Lead Sponsor:
Janssen, LP
Conditions:
Schizoaffective Disorder
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare three strategies for switching patients with schizophrenia or schizoaffective disorder to the atypical antipsychotic, risperdone, after they have been unsuccess...
Detailed Description
Data regarding the safety and effectiveness of different strategies for switching subjects with schizophrenia from one antipsychotic medication to another are very rare. Studies that have examined var...
Eligibility Criteria
Inclusion
- Patients who have a DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) diagnosis of schizophrenia or schizoaffective disorder
- Taking a stable dose of olanzapine for at least 30 days
- Have not experienced an acute exacerbation of their psychotic symptoms in the preceding 3 months
- Either had only a marginal clinical response to olanzapine, or had unacceptable side effects related to weight gain including obesity, diabetes or abnormal glucose metabolism
Exclusion
- Patients with a history of treatment failure with, or significant adverse events attributable to, risperidone, or known sensitivity to risperidone
- A history of antipsychotic therapy other than olanzapine in the 30 days preceding randomization
- Presence of serious or unstable illnesses: liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric or metabolic disturbances
- Diagnosis of substance dependence
- Pregnant or nursing female, or those lacking adequate contraception
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2002
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00378183
Start Date
February 1 2001
End Date
May 1 2002
Last Update
April 27 2010
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