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

NCT ID: NCT00458367

Last Updated: 2010-10-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5296 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2002-06-30
• Study Completion Date: 2006-10-31

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, 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.

Conditions

Schizophrenia; Psychotic Disorders; Schizoaffective Disorder

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

001

Open label risperidone long acting injectable intramuscular injections every 2 weeks for 26 weeks flexible dose 25 to 50 mg

Open label risperidone long acting injectable

Intervention Type: DRUG

intramuscular injections every 2 weeks for 26 weeks, flexible dose 25 to 50 mg

Interventions

Open label risperidone long acting injectable

intramuscular injections every 2 weeks for 26 weeks, flexible dose 25 to 50 mg

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutica N.V., Belgium

INDUSTRY

Sponsor Role: lead

Responsible Party

Janssen-Cilag S.A., Spain

Principal Investigators

Janssen Pharmaceutica N.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica N.V.

Other Identifiers

CR003373

Identifier Type: -

Identifier Source: org_study_id