Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents

Otsuka Pharmaceutical Development & Commercialization, Inc.

Overview

The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Schizophrenia Mania

Interventions

AripiprazoleDRUG

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children and adolescents between 10-17 years, in good physical health, preferentially with a primary schizophrenia spectrum diagnosis or bipolar spectrum disorder Exclusion Criteria: * History of mental retardation * Any neurological disorder with the exception of Pervasive Developmental Disorder (PDD), Attention Deficit Hyperactivity Disorder (ADHD), and Tourette's Syndrome

Data from ClinicalTrials.gov

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