Phase IV Long-term Maintenance Study of Aripiprazole in the Treatment of Irritability Associated With Autistic Disorder

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 4

Conditions

Irritability Associated With Autistic Disorder

Treatments

Drug: Placebo

Drug: Aripiprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT01227668

CN138-603

Details and patient eligibility

About

The purpose of this study is to determine whether pediatric participants with irritability associated with autistic disorder who have responded to aripiprazole treatment will experience a relapse significantly later when continuing therapy with aripiprazole than will participants who receive placebo

Full description

Phase 1: Single blind/ Phase 2: Double blind

Enrollment

215 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Male or female children or adolescents, 6 to 17 years of age, inclusive, at the time of the baseline visit
Meets current diagnostic criteria of the Diagnostic and Statistical Manual-of Mental Disorders IV-Text Revised for autistic disorder and displays behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems. Diagnosis of autistic disorder will be confirmed by the Autism Diagnostic Interview-Revised.
Participant or designated guardian or caregiver is able to comprehend and satisfactorily comply with the protocol requirements, in the opinion of the investigator.
Demonstrates behaviors such as tantrums, aggression, or self-injury or a combination of these problems
An Aberrant Behavior Checklist Irritability subscale score ≥18 AND a Clinical Global Impressions Severity score ≥4 at the Screening and Baseline Visits.
Mental age of at least 24 months

Key Exclusion Criteria:

Treatment resistant to neuroleptic medication, based on lack of therapeutic response to 2 different neuroleptics after treatment for at least 3 weeks each.
Previous treatment with aripiprazole for at least 3 weeks duration at an adequate daily dose, without demonstrating a clinically meaningful response.
Lifetime diagnosis of bipolar disorder, psychosis, or schizophrenia, or a current diagnosis of major depressive disorder
Diagnosis of Pervasive Developmental Disorder-Not Otherwise Specified, Asperger's Syndrome, Rett's Syndrome, childhood disintegrative disorder, or Fragile X Syndrome
History of neuroleptic malignant syndrome
At significant risk for suicide based on history or routine psychiatric status examination
A seizure within the past year
History of severe head trauma or stroke
History or current evidence of any unstable medical conditions that would expose the patient to undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial
Weight lower than 15 kg
Known allergy or hypersensitivity to aripiprazole or other dihidrocarbostyrils
History of a clinically significant low white blood cell count or a drug-induced leukopenia/neutropenia
Any other medically significant abnormal laboratory test or vital sign result or electrocardiogram finding