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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00102479
Recruitment Status : Completed
First Posted : January 31, 2005
Last Update Posted : April 17, 2006
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

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

Condition or disease Intervention/treatment Phase
Schizophrenia Mania Drug: Aripiprazole Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Test PK Tolerability in Children and Adolescents
Study Start Date : July 2004
Study Completion Date : July 2005

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Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00102479     History of Changes
Other Study ID Numbers: 31-03-238
First Posted: January 31, 2005    Key Record Dates
Last Update Posted: April 17, 2006
Last Verified: April 2006

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
acute mania in pediatric populations

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs