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

Primary Purpose

Schizophrenia, Mania

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Pharmacokinetics,, Aripiprazole, acute mania in pediatric populations

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 29, 2005
    Last Updated
    April 13, 2006
    Sponsor
    Otsuka Pharmaceutical Development & Commercialization, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00102479
    Brief Title
    Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents
    Official Title
    A Phase II Study to Test PK Tolerability in Children and Adolescents
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Otsuka Pharmaceutical Development & Commercialization, Inc.

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia, Mania
    Keywords
    Pharmacokinetics,, Aripiprazole, acute mania in pediatric populations

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Aripiprazole

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18626272
    Citation
    Findling RL, Kauffman RE, Sallee FR, Carson WH, Nyilas M, Mallikaarjun S, Shoaf SE, Forbes RA, Boulton DW, Pikalov A. Tolerability and pharmacokinetics of aripiprazole in children and adolescents with psychiatric disorders: an open-label, dose-escalation study. J Clin Psychopharmacol. 2008 Aug;28(4):441-6. doi: 10.1097/JCP.0b013e31817dd520.
    Results Reference
    derived

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

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