Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00294008
Status:
COMPLETED
Last Update Posted:
2014-04-03
First Post:
2006-02-16
Brief Title:
A Study to Evaluate Treatment Adherence in Schizophrenia With Long Acting Risperidone Microspheres e-STAR
Sponsor:
Janssen Korea Ltd Korea
Organization:
Janssen Korea Ltd Korea
Study Overview
Official Title:
Electronic Schizophrenia Treatment Adherence Registrye-STAR An Observational International Study to Evaluate Treatment Adherence in Schizophrenia With Long Acting Risperidone Microspheres
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:
None
Brief Summary:
This study is a non-interventional web based registry designed to assess demographic treatment and outcomes data in patients receiving treatment with long-acting injectable risperidone One year retrospective data and 2 year prospective data will be collected
Detailed Description:
This study is a multicentre retrospective and prospective observational cohort design determining aggregate drug usage patterns and commonly used clinical outcomes associated with the use of long-acting injectable risperidone The objectives of this study are to collect sufficient retrospective outcome data to allow the evaluation of treatment outcomes with long acting medication compared to previous treatments and to document clinical effectiveness and long-term treatment outcomes in actual practice Additional objectives are to prospectively assess medication usage patterns and to evaluate reasons for initiation andor discontinuation of new antipsychotic medications The study design is a non-interventional single-arm observational survey on the use of long-acting injectable risperidone and other long-acting depot or oral atypical antipsychotics with the aim to assess patient outcomes by existing risk or disease factors patient characteristics or previous medication Having reached agreement with the patient on starting treatment with long-acting injectable risperidone physicians have the opportunity to document the patients clinical data in the Registry At baseline data will be collected retrospectively over a minimum period of 12-months per patient Data will be collected prospectively over a 24-month period per patient at approximately 3-month intervals after starting treatment This study will document data of patients for whom treatment with the new antipsychotic medication is indicated and who are being treated according to the local label The start date for collecting data is the date the new antipsychotic treatment is initiated whether as inpatient or outpatient The preceding 12 months and the next 2 years are respectively for each patient the retrospective and prospective periods of interest All patients starting with a new antipsychotic medication decided after agreement between the physician and the patient in accordance with the local label are eligible for inclusion in this survey While patients participating in randomized clinical trials are not excluded their participation will be noted Data will be entered by the treating physician All data collected must be the result of the normal medical care of the patient No intervention on treatment decisions permitted The patients baseline data will be collected within the first week following initiation of the new antipsychotic treatment Prospective data collection has to occur 3 months 6 months 9 months 12 months 15 months 18 months 21 months and 24 months after initiation of the new antipsychotic treatment If a patient stops the newly initiated antipsychotic treatment the reason for discontinuation has to be reported Patients discontinuing newly initiated antipsychotic treatment will continue to be followed for up to 24 months In retrospective period the following treatment outcomes will be assessed patient characteristics treatment history with antipsychotics and other concomitant medication hospitalization history reason for initiating the new antipsychotic treatment treatment satisfaction remission clinical global impression CGI-severity global assessment of functioning GAF and clinical deterioration In prospective period clinical effectiveness will be assessing the following employment status remission treatment satisfaction CGI-severity GAF clinical deterioration hospitalization treatment adherence and serious adverse events Long-acting injectable risperidone is flexible dose 25mg to 75mg intramuscular injection given into gluteus for 24 months
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