Status:
COMPLETED
A Study to Evaluate Treatment Adherence in Schizophrenia With Long Acting Risperidone Microspheres (e-STAR)
Lead Sponsor:
Janssen Korea, Ltd., Korea
Conditions:
Schizophrenia
Tranquilizing Agents
Eligibility:
All Genders
18+ years
Brief Summary
This study is a non-interventional web based registry designed to assess demographic, treatment and outcomes data in patients receiving treatment with long-acting injectable risperidone. One year retr...
Detailed Description
This study is a multicentre, retrospective and prospective observational, cohort design, determining aggregate drug usage patterns and commonly used clinical outcomes associated with the use of long-a...
Eligibility Criteria
Inclusion
- Patients starting treatment with a new antipsychotic medication
- Permitted by their physician to participate in a clinical trial
- Patients with schizophrenia or schizoaffective disorder
- Patients who are an ambulant or not chronically hospitalized for maximal 6 months at the moment of initiation of study
- Patients and/or his/her relative, guardian or legal representative has signed the informed consent form
Exclusion
- First antipsychotic treatment ever
- Participating in any other drug study
- Chronically hospitalized and according to physician no possibility of being discharged within the planned observation period
- On clozapine during the last 3 months
- Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities
- Previous sensitivity history to risperidone and treatment resistant schizophrenia
- Pregnant or breast-feeding female
- Female with planned pregnancy within two years
Key Trial Info
Start Date :
December 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00294008
Start Date
December 1 2004
End Date
June 1 2009
Last Update
April 3 2014
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