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

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Collaborator: Otsuka America Pharmaceutical
• Treatments: Aripiprazole

Criteria

Inclusion Criteria:

• 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).

• CGI score > = 4 AND an ABC Irritability/Agitation subscale score > = 18 at screening and baseline (randomization)

• Mental age of at least 18 months

• Male or female 6 to 17 years of age inclusive, at the time of randomization

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 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