Status:
COMPLETED
A Study of the Efficacy and Safety of Long-acting Injectable Risperidone and Risperidone Tablets in Patients With Schizophrenia
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Schizophrenia
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of risperidone, formulated as a long-acting injectable drug, compared with risperidone tablets in the treatment of patients with 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 by the criteria of Diagnostic and Statistical Manual of Mental Diseases, 4th Edition (DSM-IV )
- treatment with an antipsychotic drug (up to 6 milligrams/day of risperidone or equivalent dose) for 28 days before study initiation with no change in the dosage
- Total Positive and Negative Syndrome Scale (PANSS) score \>=60 and \<120 at start of study.
Exclusion
- Diagnosis of mental disease other than schizophrenia
- treated with a sustained-release injection of other antipsychotic medications within 60 days before the initiation of the study
- history of cerebrovascular accident, convulsive disorder such as epilepsy, diabetes mellitus, liver disease, kidney disease, cardiovascular disorder, malignancy or physical exhaustion due to dehydration or malnutrition
- have risk factors of diabetes mellitus, such as hyperglycemia.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT00240708
Start Date
June 1 2004
End Date
April 1 2006
Last Update
May 17 2011
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