Status:
COMPLETED
A Comparison of the Effectiveness and Safety of Injectable Risperidone With That of Risperidone Tablets in the Treatment of Patients With Chronic Schizophrenia
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Schizophrenia
Psychotic Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The primary purpose of the study is to show that treatment with an injectable formulation of risperidone is not less effective than and has a similar safety profile to risperidone tablets in patients ...
Detailed Description
Chronic schizophrenia is a longer-term condition that is characterized by a lack of drive, underactivity and slowness, and social withdrawal. As with the acute form of schizophrenia, delusions and hal...
Eligibility Criteria
Inclusion
- Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) criteria
- total score on the PANSS at study entry of \>=50
- before trial entry, results of clinical hematology, biochemistry, and urinalysis tests performed at screening visit are within normal ranges
- women of child-bearing age must use adequate birth control methods, have a negative pregnancy test before the start of risperidone treatment, and not be breast feeding
- patients' schizophrenia symptoms are stable for the last 4 weeks of the run-in period.
Exclusion
- Patients with a DSM-IV Axis I diagnosis other than schizophrenia
- documented disease of the central nervous system that can interfere with the trial assessments, for example stroke, tumor, Parkinson's Disease, Alzheimer's Disease
- moderate or severe symptoms at screening of tardive dyskinesia, a condition of uncontrollable movements of the tongue, lips, face, trunk, hands and feet that is seen in patients receiving long-term medication with certain types of antipsychotic drugs
- history of neuroleptic malignant syndrome, a rare condition in patients receiving antipsychotic medication in which patients may develop fever, sweating, unstable blood pressure, rigid muscles, and other symptoms, including changes in their normal mental state
- acute, unstable or other significant and untreated medical conditions, such as infections, unstable diabetes, or unstable hypertension.
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2000
Estimated Enrollment :
641 Patients enrolled
Trial Details
Trial ID
NCT00249223
Start Date
January 1 2000
End Date
December 1 2000
Last Update
January 14 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.