Status:
COMPLETED
Phase IV Long-term Maintenance Study of Aripiprazole in the Treatment of Irritability Associated With Autistic Disorder
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Irritability Associated With Autistic Disorder
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief Summary
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 sign...
Detailed Description
Phase 1: Single blind/ Phase 2: Double blind
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT01227668
Start Date
March 1 2011
End Date
June 1 2012
Last Update
May 2 2014
Active Locations (38)
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1
Harmonex Neuroscience Research, Inc
Dothan, Alabama, United States, 36303
2
Southwest Autism Research And Resource Center
Phoenix, Arizona, United States, 85006
3
Clinical Innovations, Inc.
Costa Mesa, California, United States, 92626
4
Behavioral Research Specialists, Llc
Glendale, California, United States, 91206