Non-Interventional Observational Registry Designed to Assess Treatment and Outcomes Data in Patients Receiving Treatment With Risperdal Consta. Two Years Retrospective Data and 2 Years Prospective Data Will be Collected and Compared. - Full Text View

Sponsored by:	Janssen Cilag N.V./S.A.
Information provided by:	Janssen Cilag N.V./S.A.
ClinicalTrials.gov Identifier:	NCT00774085

Purpose

Non-interventional observational registry designed to assess treatment and outcomes data in patients receiving treatment with Risperdal Consta. Two years retrospective data and 2 years prospective data will be collected and compared.

Condition	Phase
Schizophrenia	Phase IV

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone

U.S. FDA Resources

Study Type:	Observational
Official Title:	Electronic Schizophrenia Treatment Adherence Registry

Further study details as provided by Janssen Cilag N.V./S.A.:

Estimated Enrollment:	400
Study Start Date:	November 2004
Study Completion Date:	December 2007

Detailed Description:

This protocol proposes a multicentre, retrospective and prospective drug utilisation review, determining drug usage patterns and outcomes associated with the use of risperidone long acting, in clinical practice. In addition, this study is proposed in Belgium to satisfy the request from Belgian Reimbursement Authorities to collect clinical data on the impact of risperidone long acting on treatment compliance, number of hospitalisations and potential prevention of relapses. Also, these data will provide documentation on switch from oral to parenteral treatment. The objectives of the Electronic Schizophrenia Treatment Adherence Registry are to: collect clinical outcome data at the request of the Belgian Reimbursement Authorities; prospectively assess medication usage patterns, to document clinical efficacy and long-term treatment outcomes of risperidone long acting, in a naturalistic setting; collect retrospective data, to compare with risperidone long acting; document reasons for initiating risperidone; collect data on switch of treatment to risperidone long acting.

Risperidone long acting at the following dose: 25, 37.5, 50 mg per intramuscular injection. Usage according to label was recommended.

Eligibility

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

Criteria

Inclusion Criteria:

Patient who started Risperdal Consta treatment after agreement between doctor and patient
Ambulatory patient or not chronically full-time hospitalised patient. Full-time hospitalization at the moment of inclusion for maximal 6 months
The treatment and treated indication according to local label
Patient had given informed consent in agreement with local legislation

Exclusion Criteria:

Patient participating in another drug related trial, chronically full-time hospitalized patient, who according to the treating physician had no perspective of being discharged within the planned observation period
Patient suffering from treatment resistant schizophrenia
Pregnant or breastfeeding females or females with planned pregnancy within two years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774085

Sponsors and Collaborators

Janssen Cilag N.V./S.A.

Investigators

Study Director:

Janssen-Cilag N.V./S.A., Belgium Clinical Trial

Janssen Cilag N.V./S.A.

More Information

Study ID Numbers:	CR003886
Study First Received:	October 16, 2008
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00774085
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Janssen Cilag N.V./S.A.:

Risperdal Consta
Risperidone
Schizophrenia

Study placed in the following topic categories:

Schizophrenia
Dopamine
Mental Disorders
Risperidone

Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009