Overview

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

Status:
Completed
Trial end date:
2008-04-01
Target enrollment:
0
Participant gender:
All
Summary
This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, 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 for Mental Disorders-Fourth Edition
(DSM-IV) diagnostic criteria for AD and demonstrates serious behavioral problems.
Diagnosis confirmed by Autism Diagnostic Interview- Revised (ADI-R)

- CGI score > = 4 AND and Aberrant Behavior Checklist (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, or schizophrenia, or major
depression

- A seizure in the past year

- History of severe head trauma or stroke

- Patients undergoing non-pharmacologic therapies (e.g., psychotherapy, behavioral
modification) must have started at least 2 months prior to the initial screening visit
and must remain in a consistent treatment program for the duration of the study.