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

Otsuka

Status and phase: Completed; Phase 3

Conditions: Autistic Disorder; Behavioral Symptoms

Treatments: Drug: Placebo; Drug: Aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00337571

CN138-179

Details and patient eligibility

About

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).

Enrollment: 218 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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218 participants in 4 patient groups, including a placebo group

A1

Experimental group

Description:

5 mg

Treatment:

Drug: Aripiprazole

A2

Experimental group

Description:

10 mg

Treatment:

Drug: Aripiprazole

A3

Experimental group

Description:

15 mg

Treatment:

Drug: Aripiprazole

B1

Placebo Comparator group

Treatment:

Drug: Placebo