Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)
Condition: Autistic Disorder; Behavioral Symptoms
MeSH terms: Autistic Disorder; Behavioral Symptoms; Problem Behavior
Intervention: Aripiprazole
Intervention description: Tablets, Oral, 2, 5, 10, or 15 mg, once daily, 52 weeks
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 330.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Serious behavioral problems in children and adolescents with AD; behavioral problems

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 aripiprazole (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]).
    

Eligibility criteria:

        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