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Sponsors and Collaborators: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Janssen, LP |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00236548 |
The purpose of this study is to assess the usefulness of the Risperdal® Consta® Treatment Guidebook in helping the doctor switch the adult patient from taking risperidone tablets daily by mouth to taking long-acting risperidone by injection. The study will also evaluate the effectiveness and safety of long-acting risperidone and its effect on patient satisfaction.
Condition | Intervention | Phase |
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Psychotic Disorders Schizophrenia |
Drug: risperidone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | An Open-Label Evaluation of the Utility of the RISPERDAL® CONSTA® Treatment Guidebook During Transition of Adult Patients With Schizophrenia or Schizoaffective Disorder to RISPERDAL® CONSTA® (Risperidone) Treatment Over Three Months in the Community Mental Health Center (CMHC) Setting |
Estimated Enrollment: | 60 |
Estimated Study Completion Date: | January 2003 |
Many patients who take oral medication to treat schizophrenia or schizoaffective disorder have trouble taking their medication every day. They may not want to take it, or they may just forget. Risperidone injections, given once every 2 weeks, are expected to be just as effective as risperidone tablets taken once a day. The option of getting an injection every 2 weeks rather than taking a tablet every day may help patients keep to their medication administration schedule and could help to reduce the symptoms of their disease. The study will assess the usefulness of the Risperdal® Consta® Treatment Guidebook in a Community Mental Health Center setting, over a period of three months. This Guidebook was designed to help doctors switch adult patients from oral risperidone tablets to long-acting risperidone given once every 2 weeks by injection. During the study, patients will continue to take oral risperidone for 2 weeks following initiation of risperidone injections, which will be given every 2 weeks during a 12-week period. Physical examinations and laboratory tests will be performed to test the safety of the risperidone injections. Both the patient and the doctor will be asked questions about the usefulness of the guidebook and the effectiveness of the injections. The objective of this study is to demonstrate the effectiveness of the Risperdal® Consta™ Treatment Guidebook in switching patients with schizophrenia and schizoaffective disorder from daily oral risperidone to long-acting risperidone injections. In addition, safety evaluations are assessed throughout the study.
Risperidone oral tablets, 2 to 6 milligrams per day for the first 2 weeks after initiation of long-acting risperidone injections; long-acting risperidone injections are given in doses of 25, 37.5, or 50 milligrams per 2 milliliter injection once every 2 weeks for 12 weeks.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR002896 |
Study First Received: | October 7, 2005 |
Last Updated: | May 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00236548 |
Health Authority: | United States: Food and Drug Administration |
patient compliance Treatment Guidebook intramuscular injection |
schizoaffective disorder long-acting risperidone Schizophrenia |
Schizophrenia Dopamine Mental Disorders Risperidone |
Psychotic Disorders Serotonin Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Disease 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 Pathologic Processes Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |