Status:
COMPLETED
A Study of Treatment Success in Changing From Olanzapine to Long-acting Injectable Risperidone (RISPERDAL® CONSTA™)
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Schizophrenia
Psychotic Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to evaluate the maintained effectiveness of long-acting injectable risperidone (RISPERDAL® CONSTA™) compared with the previous treatment with oral olanzapine in non-acute s...
Detailed Description
Although many schizophrenia patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regimen. Long-acting injectable fo...
Eligibility Criteria
Inclusion
- Diagnosis of schizophrenia or schizoaffective disorder according to criteria of Diagnostic and StatisticalManual of Mental Diseases, 4th edition (DSM-IV)
- patients must have been symptomatically non-acute on a stable dose of olanzapine the last month before the screening visit
- patients must be currently treated with oral olanzapine at doses stable for the last month and willing to switch to long-acting injectable risperidone for one of the following reasons: insufficient treatment response, adverse events, compliance issues, or patient's request.
Exclusion
- Patients not treated with effective doses of olanzapine (acc. to SmPC) prior to study initiation
- known hypersensitivity, intolerance, or unresponsiveness to risperidone
- history of drug allergy or neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
- tardive dyskinesia, a complication of neuroleptic therapy involving involuntary movements of facial muscles
- pregnant or nursing females, or those lacking adequate contraception
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00216632
Start Date
March 1 2005
End Date
July 1 2007
Last Update
December 7 2012
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