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Status:

COMPLETED

Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)

Lead Sponsor:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborating Sponsors:

Otsuka America Pharmaceutical

Conditions:

Autistic Disorder

Behavioral Symptoms

Eligibility:

All Genders

6-17 years

Phase:

PHASE3

Brief Summary

This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripipra...

Eligibility Criteria

Inclusion

  • Inclusion Criteria - Rollover:
  • Completed 8 weeks of treatment in one of the following double-blind clinical trials: CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]
  • No significant protocol violations and sufficient medical justification to continue on open-label treatment with aripiprazole
  • Inclusion Criteria - De Novo:
  • Meets current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) diagnostic criteria for AD and demonstrates serious behavioral problems - diagnosis confirmed by Autism Diagnostic Interview-Revised (ADI-R) or the patient meets the current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) diagnostic criteria for AD and has a history of behavioral problems that are currently being treated with psychotropic medication
  • Mental age of at least 18 months
  • Male or female 6 to 17 years of age, inclusive, at the time of enrollment
  • Exclusion Criteria:
  • Patients considered treatment resistant to neuroleptic medication based on lack of therapeutic response to 2 different neuroleptics after treatment of at least 3 weeks each
  • Patients previously treated and not responding to aripiprazole treatment
  • The patient is currently diagnosed with another disorder on the autism spectrum, including pervasive developmental disorder-not otherwise specified (PDD-NOS), Asperger's Disorder, Rett's Disorder, Fragile-X Syndrome or Childhood Disintegrative Disorder
  • Current diagnosis of bipolar disorder, psychosis, schizophrenia, or major depression
  • A seizure in the past year
  • History of severe head trauma or stroke
  • Non-pharmacologic therapy (e.g. psychotherapy, behavior modification) should be stable prior to screening and consistent throughout the study

Exclusion

    Key Trial Info

    Start Date :

    September 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2009

    Estimated Enrollment :

    330 Patients enrolled

    Trial Details

    Trial ID

    NCT00365859

    Start Date

    September 1 2006

    End Date

    June 1 2009

    Last Update

    December 2 2013

    Active Locations (55)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 14 (55 locations)

    1

    University of Alabama at Birmingham

    Birmingham, Alabama, United States, 35203

    2

    Harmonex Neuroscience

    Dothan, Alabama, United States, 36303

    3

    Southwest Autism Research and Resource Center

    Phoenix, Arizona, United States, 85006

    4

    Univ of Arizona

    Tuscon, Arizona, United States, 85724-5002