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Phase IV Long-term Maintenance Study of Aripiprazole in the Treatment of Irritability Associated With Autistic Disorder | Clinical Trials | Clareo Health

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

Safety and Efficacy of Aripiprazole in the Long-term Maintenance Treatment of Pediatric Patients With Irritability Associated With Autistic Disorder

NCT01227668•Bristol-Myers Squibb

View on ClinicalTrials.gov

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 significantly later when continuing therapy with aripiprazole than will participants who receive placebo

Detailed Description

Phase 1: Single blind/ Phase 2: Double blind

Eligibility

Age

6 - 17 years

Sex

ALL

Healthy Volunteers

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

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
+3 more criteria

Locations (38)

Harmonex Neuroscience Research, Inc

Dothan, Alabama, United States

Southwest Autism Research And Resource Center

Phoenix, Arizona, United States

Clinical Innovations, Inc.

Costa Mesa, California, United States

Behavioral Research Specialists, Llc

Glendale, California, United States

Abbey Neuropsychology Clinic

Palo Alto, California, United States

Ucsf - Lppi

San Francisco, California, United States

Stanford University School Of Medicine

Stanford, California, United States

Children'S National Medical Center

Washington D.C., District of Columbia, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

Palm Springs Research Institute

Hialeah, Florida, United States

Key Dates

Start Date

March 1, 2011

Primary Completion Date

June 1, 2012

Completion Date

June 1, 2012

Last Updated

May 2, 2014

Enrollment

215

ACTUAL participants

Conditions

Irritability Associated With Autistic Disorder

Interventions

Aripiprazole

DRUG

Placebo

DRUG