Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304655
Status:
COMPLETED
Last Update Posted:
2009-12-17
First Post:
2006-03-17
Brief Title:
Acute Psychosis Treatment in the Long Term Unitary Group Study APLUS
Sponsor:
Korea Otsuka Pharmaceutical Co Ltd
Organization:
Korea Otsuka Pharmaceutical Co Ltd
Study Overview
Official Title:
Multicenter Single Group Study of Aripiprazole Efficacy and Safety in the Acute Psychosis Treatment of Schizophrenia Schizophreniform Disorder and Schizoaffective Disorder
Status:
COMPLETED
Status Verified Date:
2009-12
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 prove safety and efficacy of aripiprazole
Detailed Description:
This study was designed to prove safety and efficacy of aripiprazole in the treatment of acutely relapsed patients with diagnoses of schizophrenia or schizoaffective disorder in Korea and to confirm the maintenance of efficacy and safety during maintenance period and the changes in emotional factors and social functions
After administering 15 mgday of aripiprazole for two weeks the test may change the dose within the range of 10 mg and 30 mg per day by clinical judgment Medication duration 8 weeks acute phase 18 weeks maintenance phase 26 weeks extension phase total 52 weeks
After administering 15 mgday of aripiprazole for two weeks the test may change the dose within the range of 10 mg and 30 mg per day by clinical judgment Medication duration 8 weeks acute phase 18 weeks maintenance phase 26 weeks extension phase total 52 weeks
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