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

October 22, 2010
August 14, 2012
March 2011
June 2012   (final data collection date for primary outcome measure)
Time from randomization to relapse [ Time Frame: Every 2 weeks for 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01227668 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
OPT - Phase IV Long Term Maintenance Study of Aripiprazole for 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

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

Phase 1: Single Blind/ Phase 2: Double Blind

Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Autistic Disorder
  • Drug: Aripiprazole
    Tablets, Oral, 2-15 mg, once daily, 13-42 weeks
    Other Names:
    • BMS-337039
    • Abilify
  • Drug: Placebo
    Tablets, Oral, 0 mg, once daily, 16 weeks
  • Experimental: Aripiprazole
    Intervention: Drug: Aripiprazole
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Findling RL, Mankoski R, Timko K, Lears K, McCartney T, McQuade RD, Eudicone JM, Amatniek J, Marcus RN, Sheehan JJ. A randomized controlled trial investigating the safety and efficacy of aripiprazole in the long-term maintenance treatment of pediatric patients with irritability associated with autistic disorder. J Clin Psychiatry. 2014 Jan;75(1):22-30. doi: 10.4088/JCP.13m8500.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2012
June 2012   (final data collection date for primary outcome measure)

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
6 Years to 17 Years
Contact information is only displayed when the study is recruiting subjects
United States
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP