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Sponsored by: |
Janssen, LP |
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Information provided by: | Janssen, LP |
ClinicalTrials.gov Identifier: | NCT00246194 |
The purpose of this study is to examine treatment practices of adult schizophrenia patients by their own doctors, and to assess patient outcomes when treated with long-acting risperidone injection (an antipsychotic medication) over a two-year period of observation.
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | The SOURCE Study: Schizophrenia Outcomes-Utilization, Relapse, and Clinical Evaluation: a Prospective 2-Year Observational Study of Patients With Schizophrenia Who Initiate Treatment With Injectable Risperidone Long-Acting Microspheres (RISPERDAL® CONSTA™) |
Estimated Enrollment: | 600 |
Study Start Date: | September 2004 |
Study Completion Date: | November 2007 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Controlled clinical trials for treating schizophrenia often involve selected patients with common characteristics. It is recognized that schizophrenia patients are much more diverse than those in the clinical setting, and that physicians' prescribing practices may vary. The objective of the study is to examine treatment practices for adult schizophrenic patients by their own physicians, and to assess patient outcomes when treated with long-acting risperidone injection. This is a 2-year, prospective, multi-center, longitudinal, observational study in adults with schizophrenia. Physicians will determine the appropriate treatment for their patients, according to their usual practice. Patients starting treatment with long-acting risperidone injection and meeting all the study criteria may enroll in the study. They will be administered a dose of 25, 37.5 or 50 mg of risperidone every 2 weeks by intramuscular injection, and continue their treatment for schizophrenia according to usual care by their physicians. Patients will be asked questions at baseline and every three months for a period of two years to assess: efficacy of the medication, how well the patient is functioning, use of healthcare resources (e.g., emergency room visits, hospitalizations) patient work status, quality of life and patient satisfaction with the medicine. Safety will be monitored throughout the study.
A dose of 25, 37.5 or 50 mg of risperidone, administered every 2 weeks by intramuscular injection. The study duration is 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR005035 |
Study First Received: | October 28, 2005 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00246194 |
Health Authority: | United States: Institutional Review Board |
treatment outcome long-acting risperidone Schizophrenia intramuscular injections |
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 |