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An Open-Label Trial of Aripiprazole in Children and Adolescents With Bipolar Disorder

2014-07-23 21:47:47 | BioPortfolio

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.

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 Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Bipolar Disorder

Intervention

Aripiprazole

Status

Completed

Source

University of Cincinnati

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:47:47-0400

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Medical and Biotech [MESH] Definitions

A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.

An element in the alkali metals family. It has the atomic symbol Li, atomic number 3, and atomic weight 6.94. Salts of lithium are used in treating BIPOLAR DISORDER.

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