Bipolar Disorder Clinical Trial
Official title:
An Open-Label Trial of Aripiprazole in Children and Adolescents With Bipolar Disorder
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.
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. ;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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