Ignite Creation Date:
2024-05-05 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00774085
Status:
COMPLETED
Last Update Posted:
2012-04-27
First Post:
2008-10-16
Brief Title:
An Observational Study to Assess Treatment Outcomes Data in Patients Receiving Long-Acting Injectable Risperidone
Sponsor:
Janssen Cilag NVSA
Organization:
Janssen Cilag NVSA
Study Overview
Official Title:
Electronic Schizophrenia Treatment Adherence Registry
Status:
COMPLETED
Status Verified Date:
2012-04
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:
e-STAR
Brief Summary:
The purpose of this study is to assess treatment and outcomes data in patients receiving treatment with long-acting injectable risperidone
Detailed Description:
This is an observational study in which patientsparticipants are observed and multicentre at multiple sites study This is one-country arm of a multinational study This study consists of 2 years of retrospective a study in which the patients are identified and then documented backward in time and 2 years of prospective a study in which the patients are identified and then followed forward in time for the outcome of the study study periods during which medication utilization review will be done determining medication usage patterns and outcomes associated with the use of risperidone long acting in clinical practice Usage of risperidone according to label was recommended during the study The planned recruitment period will be 6 months Retrospective observation will be 2 years for hospitalization history and at least 1 year for medication usage Total duration of prospective observation for each patient with a complete follow-up will be 24 months Data collection during the follow up period will be scheduled every 3 months 2 weeks In addition this study is proposed in Belgium to satisfy the demand from Belgian Reimbursement Authorities to collect clinical data on the impact of risperidone long acting on treatment compliance number of hospitalizations and potential prevention of relapses Also this data will provide documentation on switch from oral to parenteral treatment Data will be pooled from different physicians andor countries The objectives of this study are collect clinical outcome data at the request of the Belgian Reimbursement Authorities prospectively assess medication usage patterns to document clinical efficacy and long-term treatment outcomes of risperidone long acting in a naturalistic setting collect retrospective data to compare with risperidone long acting document reasons for initiating risperidone collect data on switch of treatment to risperidone long acting
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 |
|---|---|---|---|
| 2004-002448-93 | EUDRACT_NUMBER | Janssen Cilag NVSA Belgium | None |
| RISSCH4002 | OTHER | None | None |