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

Otsuka

Status and phase

Completed

Phase 3

Conditions

Autistic Disorder

Treatments

Drug: Placebo

Drug: Aripiprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00332241

CN138-178

Details and patient eligibility

About

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).

Enrollment

98 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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.