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

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

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

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders; Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Drug: Open label risperidone long acting injectable

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.

• Study Type: Observational
• Enrollment (Actual): 5296

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
001; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	at baseline and at month 1, 3 and 6.

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate effectiveness of risperidone long acting injectable (using Clinical Global Impression scale-Severity and Change)	Baseline and at month 1, 3 and 6
To evaluate effectiveness of risperidone long acting injectable (using Global Assessment of Functioning scale)	Baseline and at month 1, 3 and 6

Collaborators and Investigators

• Sponsor: Janssen Pharmaceutica N.V., Belgium

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Study Completion (ACTUAL): October 1, 2006

Study Registration Dates

• First Submitted: April 6, 2007
• First Submitted That Met QC Criteria: April 6, 2007
• First Posted (ESTIMATE): April 10, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): October 18, 2010
• Last Update Submitted That Met QC Criteria: October 15, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: PASS; Safety Assessment; Efficacy Assessment; long-acting injectable risperidone
• Additional Relevant MeSH Terms: Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Disease; Psychotic Disorders; Mental Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: CR003373