OPT - Phase IV Long Term Maintenance Study of Aripiprazole for the Treatment of Irritability Associated With Autistic Disorder

• Mean change from end of Phase 1 to Week 16 endpoint (LOCF) on the Aberrant Behavior Checklist - Irritability Subscale [ Time Frame: Every 2 weeks for 16 weeks ] [ Designated as safety issue: No ]
• Mean Clinical Global Impression - Improvement scale score at Week 16 endpoint (LOCF) [ Time Frame: Every 2 weeks for 16 weeks ] [ Designated as safety issue: No ]

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

Phase 1: Single Blind/ Phase 2: Double Blind

• Drug: Aripiprazole
  Tablets, Oral, 2-15 mg, once daily, 13-42 weeks
  Other Names:

  • BMS-337039
  • Abilify
• Drug: Placebo
  Tablets, Oral, 0 mg, once daily, 16 weeks

• Experimental: Aripiprazole
  Intervention: Drug: Aripiprazole
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

Inclusion Criteria:

• Meets current DSM-IV-TR diagnostic criteria for autistic disorder (confirmed by the ADI-R)
• Demonstrates behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems
• CGI-S score ≥ 4 AND an ABC Irritability subscale score ≥ 18 at the Screening and Baseline Visits
• Mental age of at least 24 months

Exclusion Criteria:

• Treatment resistance to neuroleptic medication
• Lifetime diagnosis of bipolar disorder, psychosis, or schizophrenia, or a current diagnosis of major depressive disorder
• Diagnosed with Pervasive Developmental Disorder-Not Otherwise Specified (NOS), Asperger's Syndrome, Rett's Syndrome, childhood disintegrative disorder or Fragile X Syndrome
• History of neuroleptic malignant syndrome
• Significant risk of committing suicide
• A seizure within the past year
• History of severe head trauma or stroke
• History or current evidence of any unstable medical conditions
• Weight less 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 result, vital sign result or ECG finding