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Sponsored by: |
Janssen Cilag N.V./S.A. |
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Information provided by: | Janssen Cilag N.V./S.A. |
ClinicalTrials.gov Identifier: | NCT00774085 |
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.
Study Type: | Observational |
Official Title: | Electronic Schizophrenia Treatment Adherence Registry |
Estimated Enrollment: | 400 |
Study Start Date: | November 2004 |
Study Completion Date: | December 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Risperdal Consta Risperidone Schizophrenia |
Schizophrenia Dopamine Mental Disorders Risperidone |
Psychotic Disorders Serotonin Schizophrenia and Disorders with Psychotic Features |
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 |