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

NCT00365859

CompletedPhase 3

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Conditions: Autistic Disorder, Behavioral Symptoms

Interventions: Aripiprazole

Countries: United States

This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]).

Eligibility overview

Sex: ALL

Age: 6 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria - Rollover:

* Completed 8 weeks of treatment in one of the following double-blind clinical trials: CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]
* No significant protocol violations and sufficient medical justification to continue on open-label treatment with aripiprazole

Inclusion Criteria - De Novo:

* 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) or the patient meets the current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) diagnostic criteria for AD and has a history of behavioral problems that are currently being treated with psychotropic medication
* Mental age of at least 18 months
* Male or female 6 to 17 years of age, inclusive, at the time of enrollment

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 pervasive developmental disorder-not otherwise specified (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

Locations (55)

Birmingham, Alabama, United States
Dothan, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Costa Mesa, California, United States
Rolling Hills Estates, California, United States
Sacramento, California, United States
San Diego, California, United States
Stanford, California, United States
Aurora, Colorado, United States
Boca Raton, Florida, United States
Gainesville, Florida, United States
Gainesville, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Smyrna, Georgia, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
Cambridge, Massachusetts, United States
Cambridge, Massachusetts, United States
Wellesley, Massachusetts, United States
Bloomfield Hills, Michigan, United States
Detroit, Michigan, United States
Saint Paul, Minnesota, United States
Kansas City, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
+ 25 more on CT.gov