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

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ClinicalTrials.gov Identifier: NCT00102479
Recruitment Status : Completed
First Posted : January 31, 2005
Last Update Posted : April 17, 2006
Sponsor:
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

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

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 ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00102479    
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.:
Pharmacokinetics,
Aripiprazole
acute mania in pediatric populations
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists