An observational study in Schizophrenia, Psychotic Disorders and Schizoaffective Disorder, sponsored by Janssen Pharmaceutica N.V., Belgium. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-10-18.
Sponsored by Janssen Pharmaceutica N.V., Belgium · Observational
The purpose of this research study is to gather information on the safety and efficacy of risperidone when used in routine clinical practice.
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, observational survey to compare the safety profile between groups defined by existing risk or disease factors or patient characteristics. The study duration is 6 months with 4 patient visits. The primary objective of this PASS is to confirm safety, as identified in phase III clinical trials of risperidone, by collecting data when the drug is used under marketed conditions in routine clinical practice. A secondary objective is to evaluate effectiveness and reasons for initiating risperidone. Each investigator is to document data for 4-10 treated patients for whom risperidone long-acting injectable (RLAI) treatment is determined to be clinically indicated. Risperidone long-acting injectable (RLAI) is given as intramuscular injections every 2 weeks. The starting dose of RLAI will be in accordance with the product label (usually 25 mg). If necessary, the dosage of the injection may be increased gradually. Treatment duration is 26 weeks. To ensure continued antipsychotic coverage until the main release of risperidone from the microspheres, previous antipsychotic therapy will be continued concomitantly during the first three weeks of the study.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 5,296 is above the median of 178 across 491 observational studies indexed under Schizophrenia.
Browse Schizophrenia studies →Janssen Pharmaceutica N.V., Belgium is the lead sponsor of 58 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated with long-acting injectable risperidone as decided after agreement between the physician and the patient, in accordance with the local 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 Criteria:
Open label risperidone long acting injectable intramuscular injections every 2 weeks for 26 weeks flexible dose 25 to 50 mg
Drug: Open label risperidone long acting injectable
intramuscular injections every 2 weeks for 26 weeks, flexible dose 25 to 50 mg
To confirm safety, as identified in phase III clinical trials of risperidone by collecting data (including adverse event information) when the drug is used under marketed conditions in routine clinical practice.
Time frame: at baseline and at month 1, 3 and 6.
To evaluate effectiveness of risperidone long acting injectable (using Clinical Global Impression scale-Severity and Change)
Time frame: Baseline and at month 1, 3 and 6
To evaluate effectiveness of risperidone long acting injectable (using Global Assessment of Functioning scale)
Time frame: Baseline and at month 1, 3 and 6
No study locations are listed for this record.
This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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Janssen Pharmaceutica N.V., Belgium