Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216528
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2005-09-13
Brief Title:
A Study to Evaluate Symptomatic Remission in Schizophrenia With Long Acting Risperidone Microspheres
Sponsor:
Janssen Korea Ltd Korea
Organization:
Janssen Korea Ltd Korea
Study Overview
Official Title:
A Prospective Open-Label Study to Evaluate Symptomatic Remission in Schizophrenia With Long Acting Risperidone Microspheres Risperdal Consta
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 evaluate symptomatic remission rate in patients with schizophrenia using long acting risperidone microspheres
Detailed Description:
Although most of Korean schizophrenic patients currently take oral antipsychotic medications it is estimated that up to 75 of them have difficulty adhering to daily oral regimen Long-acting injectable formulation may eliminate this need for daily medication This is a prospective open-label multicenter study to determine the long-term efficacy especially symptomatic remission rate of long-acting risperidone microspheres administrered in the muscle at 2 week intervals in patients with schizophrenia
The patients will receive intramuscular injections either 25 375 50 mg equivalent of risperidone at every 2 weeks for 1 year
The patients will receive intramuscular injections either 25 375 50 mg equivalent of risperidone at every 2 weeks for 1 year
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