Status:
COMPLETED
RiSPECT: Risperdal Safety Protocol Evaluation Consta Treatment, a Post Authorization Safety Survey to Obtain Information on the Safety and Efficacy of Risperidone When Used in Routine Clinical Practice
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Schizophrenia
Psychotic Disorders
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this research study is to gather information on the safety and efficacy of risperidone when used in routine clinical practice.
Detailed Description
This post-authorisation safety survey (PASS) is an international, multicentre, naturalistic, descriptive survey to confirm safety of risperidone in daily practice. This is a single-arm, prospective, o...
Eligibility Criteria
Inclusion
- All patients treated with long-acting injectable risperidone as decided after agreement between the physician and the patient, in accordance with the local Summary of Product Characteristics (SmPC), are eligible for inclusion in this survey. According to the global SmPC, long-acting injectable risperidone is indicated for the treatment of schizophrenia and schizoaffective disorder
Exclusion
- According to the SmPC, long-acting injectable risperidone is contraindicated in patients with a known hypersensitivity to the product or any of its components. These patients must be excluded from the survey
Key Trial Info
Start Date :
June 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
5296 Patients enrolled
Trial Details
Trial ID
NCT00458367
Start Date
June 1 2002
End Date
October 1 2006
Last Update
October 18 2010
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.