Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194012
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2005-09-11
Brief Title:
Study of Aripiprazole Abilify Versus Placebo in Children With Subsyndromal Bipolar Disorder
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
University Hospitals Cleveland Medical Center
Study Overview
Official Title:
Aripiprazole in At-Risk Children With Symptoms of Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2017-06
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 test the effectiveness and tolerabilitysafety of aripiprazole Abilify in children with subsyndromal symptoms of bipolar disorder who also have a parent with bipolar disorder and other family member with a mood disorder
Detailed Description:
This will be a double-blind placebo-controlled parallel-arm randomized clinical trial that will last up to 12 weeks
This placebo-controlled portion will be followed by a 6-week open label extensionstabilization phase In order to be eligible for participation in the extensionstabilization phase subjects must 1 in the investigators opinion have had no dose-limiting side effects likely to be attributable to aripiprazole APZ 2 participated in the blinded portion of the clinical trial for a minimum of 4 weeks
This placebo-controlled portion will be followed by a 6-week open label extensionstabilization phase In order to be eligible for participation in the extensionstabilization phase subjects must 1 in the investigators opinion have had no dose-limiting side effects likely to be attributable to aripiprazole APZ 2 participated in the blinded portion of the clinical trial for a minimum of 4 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