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Trial record 12 of 30 for:    Developmental Disabilities | ( Map: Alabama, United States )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01227668
Recruitment Status : Completed
First Posted : October 25, 2010
Results First Posted : May 2, 2014
Last Update Posted : May 2, 2014
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Irritability Associated With Autistic Disorder Drug: Aripiprazole Drug: Placebo Phase 4

Detailed Description:
Phase 1: Single blind/ Phase 2: Double blind

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Percentage of Patients Relapsing by Week 16 [ Time Frame: From end of Phase 1 (Date of randomization) to Week 16 of Phase 2 and end of treatment ]
    Time of relapse=date when patient meets relapse criteria. There are 4 definitions for relapse: 1. Patient meets the following criteria for 2 consecutive visits: (a) Aberrant Behavior Checklist Irritability score ≥25% than score at end of Phase 1 AND (b) Clinical Global Impression Improvement scale rating of 'Much Worse' or 'Very Much Worse' relative to rating at end of Phase 1. If relapse criteria met at 1 visit, 2nd visit should occur in about 1 week to reevaluate whether relapse criteria are still met. 2. Patient discontinues for "Lost to Follow-up" after a visit in which he or she met Definition 1 criteria (a&b). 3. Patient begins a prohibited drug (whether a study investigator or outside source prescribed) to treat worsening symptoms of irritability of autistic disorder after a visit where patient met Definition 1 criteria (a&b). 4. Patient discontinues due to hospitalization for worsening symptoms of irritability or due to lack of efficacy based on investigator's assessment.

Secondary Outcome Measures :
  1. Adjusted Mean Change From Baseline to Week 16 on the Aberrant Behavior Checklist Irritability (ABC-I) Subscale Score (Last Observation Carried Forward [LOCF]) [ Time Frame: From Baseline (end of Phase 1) to Week 16 of Phase 2 ]
    ABC is an informant-based checklist used to assess and classify problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0=not at all a problem to 3=the problem is severe in degree), and resolve into 5 subscales: 1) irritability, agitation; 2) lethargy, social withdrawal; 3) stereotypic behavior; 4) hyperactivity, noncompliance; and 5) inappropriate speech. The ABC can be completed by parents, special educators, psychologists, direct caregivers, nurses, and others knowing the participant. Psychometric assessment of the ABC indicates that its subscales have high internal consistency, adequate reliability, and established validity. The ABC-I Subscale Score ranges from 0 to 45, with a negative change in score signifying improvement. LOCF data set includes data recorded at a given visit or, if no observation was recorded at that visit, data carried forward from the prior visit. chg=change; BL=baseline; APR=aripiprazole; vs=versus.

  2. Change From Baseline in Mean Clinical Global Impression Improvement (CGI-I) Scale Score at Week 16 (Last Observation Carried Forward [LOCF]) [ Time Frame: From Baseline (end of Phase 1) to Week 16 of Phase 2 ]
    CG-I rating scale permits global evaluation of patient's improvement over time. At baseline (BL), CGI Severity of Illness assessment is performed, in which the clinician rates severity of patient's condition on a 7-point scale ranging from 1=no symptoms to 7=very severe symptoms. Higher total score=worse symptoms. At subsequent visits, clinician assesses patient's improvement relative to symptoms at baseline on CGI-I 7-point scale ranging from 1=very much improved to 7=very much worse. Since the drug targets irritability symptoms, the CGI focuses on severity of irritability secondary to autistic disorder. Lower score=more improved symptoms. LOCF data set includes data recorded at a given visit or, if nothing recorded, data areccarried forward from the prior visit. For secondary endpoints (endpt), hierarchical testing was used to keep overall experiment-wise type I error rate to <=0.05. diff=difference; IS=irritability scale; PA=primary analysis; signif=significance/significantly.

  3. Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation During Phase 1 [ Time Frame: Weekly from Week 1 to Week 26 and continuously to end of treatment ]
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.

Other Outcome Measures:
  1. Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Treatment-related AEs During Phase 2 [ Time Frame: Weekly from Weeks 1 through 16 (end of treatment) of Phase 2 ]
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key 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

Key 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01227668

Hide Hide 38 study locations
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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
Cleveland Clinic
Cleveland, Ohio, United States, 44104
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
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
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bristol-Myers Squibb Identifier: NCT01227668    
Other Study ID Numbers: CN138-603
First Posted: October 25, 2010    Key Record Dates
Results First Posted: May 2, 2014
Last Update Posted: May 2, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Child Development Disorders, Pervasive
Autistic Disorder
Autism Spectrum Disorder
Neurodevelopmental Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists