Phase IV Long-term Maintenance Study of Aripiprazole in the Treatment of Irritability Associated With Autistic Disorder
Condition: Irritability Associated With Autistic Disorder
MeSH terms: Autistic Disorder
Intervention: Aripiprazole; Placebo
Intervention description: Tablets, Oral, 2-15 mg, once daily, 13-42 weeks; Tablets, Oral, 0 mg, once daily, 16 weeks
Intervention MeSH terms: Aripiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 215.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether pediatric participants with irritability
      associated with autistic disorder who have responded to aripiprazole treatment will
      experience a relapse significantly later when continuing therapy with aripiprazole than will
      participants who receive placebo
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female children or adolescents, 6 to 17 years of age, inclusive, at the time
             of the baseline visit

          -  Meets current diagnostic criteria of the Diagnostic and Statistical Manual-of Mental
             Disorders IV-Text Revised for autistic disorder and displays behaviors such as
             tantrums, aggression, self-injurious behavior, or a combination of these problems.
             Diagnosis of autistic disorder will be confirmed by the Autism Diagnostic
             Interview-Revised.

          -  Participant or designated guardian or caregiver is able to comprehend and
             satisfactorily comply with the protocol requirements, in the opinion of the
             investigator.

          -  Demonstrates behaviors such as tantrums, aggression, or self-injury or a combination
             of these problems

          -  An Aberrant Behavior Checklist Irritability subscale score ≥18 AND a Clinical Global
             Impressions Severity score ≥4 at the Screening and Baseline Visits.

          -  Mental age of at least 24 months

        Key Exclusion Criteria:

          -  Treatment resistant to neuroleptic medication, based on lack of therapeutic response
             to 2 different neuroleptics after treatment for at least 3 weeks each.

          -  Previous treatment with aripiprazole for at least 3 weeks duration at an adequate
             daily dose, without demonstrating a clinically meaningful response.

          -  Lifetime diagnosis of bipolar disorder, psychosis, or schizophrenia, or a current
             diagnosis of major depressive disorder

          -  Diagnosis of Pervasive Developmental Disorder-Not Otherwise Specified, Asperger's
             Syndrome, Rett's Syndrome, childhood disintegrative disorder, or Fragile X Syndrome

          -  History of neuroleptic malignant syndrome

          -  At significant risk for suicide based on history or routine psychiatric status
             examination

          -  A seizure within the past year

          -  History of severe head trauma or stroke

          -  History or current evidence of any unstable medical conditions that would expose the
             patient to undue risk of a significant adverse event or interfere with assessments of
             safety or efficacy during the course of the trial

          -  Weight lower than 15 kg

          -  Known allergy or hypersensitivity to aripiprazole or other dihidrocarbostyrils

          -  History of a clinically significant low white blood cell count or a drug-induced
             leukopenia/neutropenia

          -  Any other medically significant abnormal laboratory test or vital sign result or
             electrocardiogram finding