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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

Information source: Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia; Psychotic Disorders; Schizoaffective Disorder

Intervention: Open label risperidone long acting injectable (Drug)

Phase: N/A

Status: Completed

Sponsored by: Janssen Pharmaceutica N.V., Belgium

Official(s) and/or principal investigator(s):
Janssen Pharmaceutica N.V. Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutica N.V.

Summary

The purpose of this research study is to gather information on the safety and efficacy of risperidone when used in routine clinical practice.

Clinical Details

Official title: Risperdal Safety Protocol Evaluation Consta Treatment; A Post Authorization Safety Survey With RISPERDAL CONSTA TM

Study design: Time Perspective: Prospective

Primary outcome: 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.

Secondary outcome:

To evaluate effectiveness of risperidone long acting injectable (using Clinical Global Impression scale-Severity and Change)

To evaluate effectiveness of risperidone long acting injectable (using Global Assessment of Functioning scale)

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, 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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

Locations and Contacts

Additional Information

Starting date: June 2002
Last updated: October 15, 2010

Page last updated: August 23, 2015

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