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

  Show 38 Study Locations
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 16, 2014