Status:
COMPLETED
A Long Term Study of Long-acting Injectable Risperidone in the Treatment of Patients With Schizophrenia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to document the long term safety of a long-acting injectable formulation of risperidone in the treatment of patients with schizophrenia who have previously been treated wi...
Detailed Description
This is an open-label, long-term study of a flexible dose of a long-acting injectable formulation of risperidone (risperidone LAI) injected into the muscle at 2 week intervals for at least 12 months i...
Eligibility Criteria
Inclusion
- Completion of RIS-USA-256 within 7 days
Exclusion
- History of neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
- Significant and untreated or unstable medical illness such as diabetes, hypertension, angina
- Serious illness of the liver, kidney, or significant disturbances of the cardiac, pulmonary, gastrointestinal, endocrine, neurological system
- Pregnant or nursing females, or those lacking adequate contraception
- Known hypersensitivity or unresponsiveness to risperidone
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00236587
Start Date
November 1 2001
End Date
February 1 2004
Last Update
June 8 2011
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