Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283517
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2006-01-27
Brief Title:
A Registry of Treatment Adherence for Patients With Schizophrenia
Sponsor:
Janssen-Cilag SA
Organization:
Janssen-Cilag SA
Study Overview
Official Title:
Electronic Schizophrenia Treatment Adherence Registry eSTAR
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 the study is to assess demographic treatment and outcome data in schizophrenia patients receiving treatment with long-acting injectable tablet or liquid formulations of first generation conventional or second generation atypical antipsychotic medications
Detailed Description:
Recent studies have suggested the superior effectiveness of second generation atypical antipsychotic medications over first generation conventional antipsychotics in preventing relapse during the treatment of schizophrenia It is estimated that a majority of patients with schizophrenia have difficulty adhering to the daily regimen of oral medications and the use of long-acting injectable antipsychotics has been shown to increase compliance This study includes both retrospective and prospective observations of the treatments and outcomes associated with antipsychotic drug therapy as well as characteristics of the patient population The study is not product specific and includes patients using therapy with long-acting injectable tablet or liquid formulations of conventional or atypical antipsychotic medications All patients who enroll in the study start treatment with a new antipsychotic medication which is to be used according to the product labeling in the local country Retrospective data collected over a minimum of 12 months include patient diagnosis age sex history of treatment with antipsychotic medications hospitalization Clinical Global Impression of severity of disease CGI-severity Global Assessment of Functioning GAF and the reason for starting a new antipsychotic treatment Prospective data collected every 3 months over 2 years are evaluated to assess the effectiveness of treatment and include the patients adherence to antipsychotic medication CGI-severity GAF and clinical deterioration of the patients condition The study investigator enters the data into a registry either electronically or on paper record forms Safety assessments include the incidence type and severity of adverse events throughout the prospective phase of the study Atypical or conventional antipsychotics as tablet liquid or injectable formulations as prescribed
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