Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261430
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2005-12-02
Brief Title:
A 2-year Study of Patients With Schizophrenia Who Are Treated With Long-acting Injectable Risperidone
Sponsor:
Janssen LP
Organization:
Janssen LP
Study Overview
Official Title:
Schizophrenia Treatment Acceptance Response Trial a 20-week Open-label Multicenter Randomized Study Comparing the Effect of the GAIN Acceptance Approach Verses the Approach-as-usual in Supporting Patient Acceptance of Long-acting Risperidone Risperdal CONSTA in Adults With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2010-04
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:
None
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:
Controlled clinical trials for treating schizophrenia often involve selected patients with common characteristics It is recognized that schizophrenia 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 injections and meeting all the study criteria may enroll in the study Patients will continue their treatment 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 hospitalizations patient work status quality of life and patient satisfaction with the medicine Safety will be monitored throughout the study A dose of 25 375 or 50 mg of risperidone administered every 2 weeks by intramuscular injection
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