Status:
COMPLETED
Observational Study in Patients With Schizophrenia Treated With Long-Acting Risperidone Injection (RISPERDAL CONSTA)
Lead Sponsor:
Janssen, LP
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to examine treatment practices of adult schizophrenia patients by their own doctors, and to assess patient outcomes when treated with long-acting risperidone injection ove...
Detailed Description
This is a 2-year, prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study), multi-center (at multiple sites), longitudinal (study that ...
Eligibility Criteria
Inclusion
- Patients had schizophrenia (disorganized, catatonic, paranoid, residual, or undifferentiated) that met disease diagnostic criteria as defined in Diagnostic and Statistical Manual of Mental Disorders IV (\[DSM-IV\]
- Requiring new treatment with long-acting risperidone injectable
- Patients were cooperative, reliable, and able to complete all aspects of the protocol
Exclusion
- Use of an investigational drug in the past 30 days
- At risk to self or others
Key Trial Info
Start Date :
September 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
532 Patients enrolled
Trial Details
Trial ID
NCT00246194
Start Date
September 1 2004
End Date
November 1 2007
Last Update
April 4 2014
Active Locations (1)
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1
Rockville, Maryland, United States