Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246194
Status:
COMPLETED
Last Update Posted:
2014-04-04
First Post:
2005-10-28
Brief Title:
Observational Study in Patients With Schizophrenia Treated With Long-Acting Risperidone Injection RISPERDAL CONSTA
Sponsor:
Janssen LP
Organization:
Janssen LP
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOURCE
Brief Summary:
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 over a two-year period of observation
Detailed Description:
This is a 2-year prospective a study in which the patients are identified and then followed forward in time for the outcome of the study multi-center at multiple sites longitudinal study that involves repeated observations of the same outcomes in the same people over long periods of time observational study study in which the investigators physicians observe the patients and measure their outcomes in adults with schizophrenia mental disorder characterized by a breakdown of thought processes and by poor emotional responsiveness Physicians will determine the appropriate treatment for their patients according to their usual practice Patients starting treatment with long-acting risperidone injection an antipsychotic medication and meeting all the study criteria will be enrolled in the study They will receive a dose of 25 375 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 eg emergency room visits and hospitalizations patient work status quality of life and patient satisfaction with the medicine Safety will be monitored throughout the study duration of 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RISSCH4001 | OTHER | Janssen LP | None |
| RIS-OUT-173 | OTHER | None | None |