Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221416
Status:
COMPLETED
Last Update Posted:
2013-06-27
First Post:
2005-09-14
Brief Title:
An Open-Label Trial of Aripiprazole in Children and Adolescents With Bipolar Disorder
Sponsor:
University of Cincinnati
Organization:
University of Cincinnati
Study Overview
Official Title:
An Open-Label Trial of Aripiprazole in Children and Adolescents With Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2013-06
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:
This is an investigator-initiated study whose primary aim is to determine the effectiveness of aripiprazole Abilify in helping persons with symptoms of mania whose current medications do not completely control those symptoms Aripiprazole is a medication that has been approved by the United States Food and Drug Administration FDA for the treatment of Schizophrenia
A secondary aim of this research is to explore whether CYP 2D6 polymorphisms are related to side effects with aripiprazole The goal of this research is to identify individuals who metabolize aripiprazole more rapidly or slowly which will potentially help the clinician make dosing adjustments and decrease the risk of adverse events
A secondary aim of this research is to explore whether CYP 2D6 polymorphisms are related to side effects with aripiprazole The goal of this research is to identify individuals who metabolize aripiprazole more rapidly or slowly which will potentially help the clinician make dosing adjustments and decrease the risk of adverse events
Detailed Description:
The primary aim of this study is to assess the effectiveness safety and tolerability of aripiprazole for the treatment of children and adolescents with bipolar disorder The secondary aim of this study is to determine if common polymorphic variations in the CYP 2D6 gene underlie the inter-individual variability in aripiprazole systemic drug exposure and the occurrence of treatment emergent side effects
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