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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00458367
• Other study ID #: CR003373
• Status: Completed
• Phase: N/A
• First received: April 6, 2007
• Last updated: October 15, 2010
• Start date: June 2002
• Est. completion date: October 2006

Study information

• Verified date: October 2010
• Source: Janssen Pharmaceutica N.V., Belgium
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5296
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutica N.V., Belgium

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	To evaluate effectiveness of risperidone long acting injectable (using Clinical Global Impression scale-Severity and Change)		Baseline and at month 1, 3 and 6	No
Secondary	To evaluate effectiveness of risperidone long acting injectable (using Global Assessment of Functioning scale)		Baseline and at month 1, 3 and 6	No