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

This study has been completed.
Sponsor:
Information provided by:
Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier:
NCT00458367
First received: April 6, 2007
Last updated: October 15, 2010
Last verified: October 2010
  Purpose

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


Condition Intervention
Schizophrenia
Psychotic Disorders
Schizoaffective Disorder
Drug: Open label risperidone long acting injectable

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Risperdal Safety Protocol Evaluation Consta Treatment; A Post Authorization Safety Survey With RISPERDAL CONSTA TM

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutica N.V., Belgium:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate effectiveness of risperidone long acting injectable (using Global Assessment of Functioning scale) [ Time Frame: Baseline and at month 1, 3 and 6 ] [ Designated as safety issue: No ]

Enrollment: 5296
Study Start Date: June 2002
Study Completion Date: October 2006
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458367

Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Investigators
Study Director: Janssen Pharmaceutica N.V. Clinical Trial Janssen Pharmaceutica N.V.
  More Information

No publications provided

Responsible Party: European Medical Affairs Director, Psychiatry, Janssen-Cilag S.A., Spain
ClinicalTrials.gov Identifier: NCT00458367     History of Changes
Other Study ID Numbers: CR003373
Study First Received: April 6, 2007
Last Updated: October 15, 2010
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Janssen Pharmaceutica N.V., Belgium:
PASS
Safety Assessment
Efficacy Assessment
long-acting injectable risperidone

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on August 20, 2014