OPT - Phase IV Long Term Maintenance Study of Aripiprazole for the Treatment of Irritability Associated With Autistic Disorder

This study has been completed.
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
First received: October 22, 2010
Last updated: August 14, 2012
Last verified: August 2012

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

Condition Intervention Phase
Autistic Disorder
Drug: Aripiprazole
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Aripiprazole in the Long-Term Maintenance Treatment of Pediatric Patients With Irritability Associated With Autistic Disorder

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Time from randomization to relapse [ Time Frame: Every 2 weeks for 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from end of Phase 1 to Week 16 endpoint (LOCF) on the Aberrant Behavior Checklist - Irritability Subscale [ Time Frame: Every 2 weeks for 16 weeks ] [ Designated as safety issue: No ]
  • Mean Clinical Global Impression - Improvement scale score at Week 16 endpoint (LOCF) [ Time Frame: Every 2 weeks for 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 215
Study Start Date: March 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aripiprazole Drug: Aripiprazole
Tablets, Oral, 2-15 mg, once daily, 13-42 weeks
Other Names:
  • BMS-337039
  • Abilify
Placebo Comparator: Placebo Drug: Placebo
Tablets, Oral, 0 mg, once daily, 16 weeks

Detailed Description:

Phase 1: Single Blind/ Phase 2: Double Blind


Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Meets current DSM-IV-TR diagnostic criteria for autistic disorder (confirmed by the ADI-R)
  • Demonstrates behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems
  • CGI-S score ≥ 4 AND an ABC Irritability subscale score ≥ 18 at the Screening and Baseline Visits
  • Mental age of at least 24 months

Exclusion Criteria:

  • Treatment resistance to neuroleptic medication
  • Lifetime diagnosis of bipolar disorder, psychosis, or schizophrenia, or a current diagnosis of major depressive disorder
  • Diagnosed with Pervasive Developmental Disorder-Not Otherwise Specified (NOS), Asperger's Syndrome, Rett's Syndrome, childhood disintegrative disorder or Fragile X Syndrome
  • History of neuroleptic malignant syndrome
  • Significant risk of committing suicide
  • A seizure within the past year
  • History of severe head trauma or stroke
  • History or current evidence of any unstable medical conditions
  • Weight less 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 result, vital sign result or ECG finding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227668

  Hide Study Locations
United States, Alabama
Harmonex Neuroscience Research, Inc
Dothan, Alabama, United States, 36303
United States, Arizona
Southwest Autism Research And Resource Center
Phoenix, Arizona, United States, 85006
United States, California
Clinical Innovations, Inc.
Costa Mesa, California, United States, 92626
Behavioral Research Specialists, Llc
Glendale, California, United States, 91206
Abbey Neuropsychology Clinic
Palo Alto, California, United States, 94306
Ucsf - Lppi
San Francisco, California, United States, 94143
Stanford University School Of Medicine
Stanford, California, United States, 94305
United States, District of Columbia
Children'S National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607
Palm Springs Research Institute
Hialeah, Florida, United States, 33012
Florida Clinical Research Center, Llc
Maitland, Florida, United States, 32751
Miami Children'S Hospital
Miami, Florida, United States, 33155
University Of South Florida
Tampa, Florida, United States, 33613
United States, Georgia
Institute For Behavioral Medicine, Llc
Smyrna, Georgia, United States, 30080
United States, Idaho
Kootenai Behavioral Health Center
Coeur D'Alene, Idaho, United States, 83814
United States, Kentucky
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States, 40202
United States, Louisiana
Lsu Health Sciences Center
Shreveport, Louisiana, United States, 71103
United States, Massachusetts
Neurocare, Inc.
Newton, Massachusetts, United States, 02459
United States, Michigan
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, United States, 48302
United States, Nevada
Center For Psychiatry And Behavioral Medicine, Inc
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Clinical Research Center Of New Jersey
Gibbsboro, New Jersey, United States, 08026
Children'S Specialized Hosp
Toms River, New Jersey, United States, 08755
United States, New York
Stony Brook University School Of Medicine
Stony Brook, New York, United States, 11794
United States, North Carolina
Unc Chapel Hill
Chapel Hill, North Carolina, United States, 27517
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44104
The Ohio State University Nisonger Center
Columbus, Ohio, United States, 43210
United States, Oklahoma
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States, 73116
Ou Physician'S Child Study Center
Oklahoma City, Oklahoma, United States, 73117
Tulsa Clinical Research, Llc
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Cyn3rgy Research
Gresham, Oregon, United States, 97030
United States, Pennsylvania
Drexel University College Of Medicine
Philadelphia, Pennsylvania, United States, 19124
Western Psychiatric Institute And Clinic
Pittsburgh, Pennsylvania, United States, 15203
United States, Tennessee
Holston Medical Group
Kingsport, Tennessee, United States, 37660
United States, Texas
Insite Clinical Research
Desoto, Texas, United States, 75115
United States, Utah
Ericksen Research And Development
Clinton, Utah, United States, 84015
United States, Virginia
Childrens Specialty Gr., Pllc
Norfolk, Virginia, United States, 23510
Virginia Treatment Center For Children
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01227668     History of Changes
Other Study ID Numbers: CN138-603
Study First Received: October 22, 2010
Last Updated: August 14, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 14, 2014