Status:
COMPLETED
A Study of Long-acting Injectable Risperidone in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to document the long-term safety and tolerability of risperidone, formulated as a long-acting injectable, in the treatment of patients with schizophrenia or schizoaffectiv...
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
- Patients must have completed the double-blind study (RIS-USA-121) or withdrawn from that study for safety reasons or due to worsening of condition as determined by results from the CGI
- diagnosis of schizophrenia or schizoaffective disorder according to criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DMS IV)
- otherwise healthy on the basis of physical examination, medical history, electrocardiogram, blood biochemistry and hematology tests, and urinalysis.
Exclusion
- Known intolerance, sensitivity, serious adverse events, or unresponsiveness to risperidone
- diagnosis of DMS IV Axis I condition other than schizophrenia or schizoaffective disorder
- diagnosis of substance abuse or dependence
- use of psychostimulants or an antipsychotic medication other than risperidone
- known disease of the central nervous system (stroke, Parkinson's Disease, Huntington's Disease, Alzheimer's Disease, cancer)
- pregnant or nursing females, or those lacking adequate contraception.
Key Trial Info
Start Date :
December 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
273 Patients enrolled
Trial Details
Trial ID
NCT00210691
Start Date
December 1 1999
End Date
February 1 2004
Last Update
November 19 2010
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