Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)

This study has been completed.
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00365859
First received: August 15, 2006
Last updated: November 7, 2013
Last verified: June 2010
  Purpose

This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]).


Condition Intervention Phase
Autistic Disorder
Behavioral Symptoms
Drug: Aripiprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 52-Week, Open-Label, Multicenter Study of the Safety and Tolerability of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs [ Time Frame: From Screening (up to 42 days prior to treatment start) through Week 52 (end of study) for SAEs; from Week 0 (Baseline) through Week 52 (End of Study) for AEs ] [ Designated as safety issue: Yes ]
    Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.

  • Mean Change From Baseline in Total Simpson-Angus Scale (SAS) At Week 8, Week 26, and Week 52 [ Time Frame: Baseline, Week 8, Week 26, Week 52 ] [ Designated as safety issue: Yes ]
    The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50. Negative change scores indicate improvement.

  • Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) At Week 8, Week 26, and Week 52 [ Time Frame: Baseline, Week 8, Week 26, Week 52 ] [ Designated as safety issue: Yes ]
    The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.

  • Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Week 8, Week 26, Week 52, and Endpoint [ Time Frame: Baseline, Week 8, Week 26, Week 52 ] [ Designated as safety issue: Yes ]
    The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.

  • Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities [ Time Frame: At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52 ] [ Designated as safety issue: Yes ]
    Abnormal metabolic criterion values include the following: fasting serum glucose ≥115 mg/dL; non-fasting serum glucose ≥ 200 mg/dL; total cholesterol ≥240 mg/dL; LDL cholesterol ≥160 mg/dL; HDL cholesterol ≤30 mg/dL; triglycerides ≥120 mg/dL (females), ≥160 mg/dL (males)

  • Number of Participants With Potentially Clinically Relevant Laboratory Hematology Abnormalities [ Time Frame: At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52 ] [ Designated as safety issue: Yes ]
    Abnormal hematology criterion values include the following: hematocrit (ages 6-17, males & females) ≤33%; hemoglobin (ages 6-17, males & females) <11.3 g/dL; leukocytes ≤2800 c/mm3 or ≥16000 c/mm3; eosinophils (ages 6-17, males & females) >17%; neutrophils <15%; platelet count ≤75,000 c/mm3 or ≥700,000 c/mm3

  • Number of Participants With Potentially Clinically Relevant Laboratory Chemistry Abnormalities [ Time Frame: At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52 ] [ Designated as safety issue: Yes ]
    Abnormal chemistry criterion values include the following: aspartate aminotransferase ≥3x upper limit of normal (ULN); alanine aminotransferase ≥3x ULN; alkaline phosphatase ≥3x ULN; lactate dehydrogenase ≥3x ULN; creatinine ≥2.0 mg/dL; uric acid, ≥10.5 mg/dL (male), ≥8.5 mg/dL (female); bilirubin (Total) ≥2.0 mg/dL; serum prolactin >ULN; creatine kinase ≥3x ULN; blood urea nitrogen ≥30 mg/dL; sodium ≤126 mEq/L or ≥156 mEq/L; potassium ≤2.5 mEq/L or ≥ 6.5 mEq/L; chloride ≤90 mEq/L or ≥118 mEq/L; calcium ≤8.2 mg/dL or ≥12 mg/dL

  • Number of Participants With Potentially Clinically Relevant Eletrocardiograph (ECG) Abnormalities [ Time Frame: At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52 ] [ Designated as safety issue: Yes ]
    These abbreviations are used in the table of ECG measurements: supraventricular (SV), baseline (BL), 1 degree (1°), atrioventricular (A-V), intraventricular (IVT), symmetrical (SYM), corrected QT interval (QTc). QRS complex is a recording of a single heartbeat on ECG corresponding to the depolarization of the right and left ventricles. PR interval is measured from beginning of P wave to beginning of QRS complex. QT interval is a measure of time between start of Q wave and end of T wave in the heart's electrical cycle. ↑ = increase from baseline, ↓ = decrease from baseline, → = "to"

  • Number of Potentially Clinically Relevant Vital Sign Abnormalities [ Time Frame: At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint) ] [ Designated as safety issue: Yes ]
    Clinically significantly abnormal vital signs met age-appropriate (heart rate cohorts: ages 5-14 & ages 15+; blood pressure cohorts: ages 6-12 & ages 13-17) criterion AND represented change from pretreatment value of at least the following magnitudes: systolic blood pressure (≥130 mmHg & ≥144 mmHg w/ increase of ≥20 mmHg) or (≤117 mmHg & ≤120 mmHg w/ decrease of ≥20 mmHg); diastolic blood pressure (≥86 mmHg & ≥92 mmHg w/ increase of ≥15 mmHg) or (≤75 mm Hg & ≤80 mmHg w/ decrease of ≥15 mmHg); heart rate (140 bpm and 120 bpm w/ increase of ≥15 bpm) or (50 bpm and 50 bpm w/ decrease of ≥15 bpm).

  • Mean Change From Baseline in Patient Weight [ Time Frame: At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint) ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline by Time Period in Body Weight Z-Score [ Time Frame: At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint) ] [ Designated as safety issue: Yes ]
    The Z-Score indicates how many standard deviations a person is from the population norm values. The body weight z-scores are designed to take into account the amount of weight gain that would be expected due to normal growth in children and adolescents. The body weight z-scores are by age and gender standardized values (corresponding to a normal distribution with mean 0 and a standard deviation of 1) of the actual weight measurements, based on the Growth Charts provided by the Centers for Disease Control (CDC; see Links section of this record).

  • Mean Change From Baseline in Patient Body Mass Index (BMI) [ Time Frame: At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint) ] [ Designated as safety issue: Yes ]
    The body mass index (BMI) is a statistical measurement which compares a person's weight and height. Though it does not actually measure the percentage of body fat, it is used to estimate a healthy body weight based on subject height.

  • Mean Change From Baseline By Time Period in BMI Z-Score [ Time Frame: At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint) ] [ Designated as safety issue: Yes ]
    The Z-Score indicates how many standard deviations a person is from the population norm values. The BMI z-scores are designed to take into account the BMI that would be expected due to normal growth in children and adolescents. The BMI z-scores are by age and gender standardized values (corresponding to a normal distribution with mean 0 and a standard deviation of 1) of the actual BMI measurements, based on the Growth Charts provided by the Centers for Disease Control (CDC; see Links section of this record).


Secondary Outcome Measures:
  • Mean Change From Baseline in Clinical Global Impression (CGI)-Severity Score at Week 52 (Endpoint, LOCF) [ Time Frame: Week 0 (Baseline), Week 52 (Endpoint, LOCF) ] [ Designated as safety issue: No ]
    CGI scale is a global evaluation of improvement over time. CGI-Severity (CGI-S) is a clinician-rated assessment that evaluates the severity of a patient's condition on a 7-point scale ranging from 1 (no symptoms) to 7 (very severe symptoms). CGI-Severity score is from 1 to 7. A negative change score signifies improvement.

  • CGI-Improvement Score at Week 52 (Endpoint, LOCF) [ Time Frame: Week 52 (Endpoint, LOCF) ] [ Designated as safety issue: No ]
    CGI scale is a global evaluation of improvement over time. CGI-Improvement (CGI-I) is a clinician rated assessment that evaluates improvement relative to symptoms at baseline on a a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). CGI-I Score is from 1 to 7. A lower score signifies larger improvement.

  • Mean Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Score at Week 52 (Endpoint, LOCF) [ Time Frame: Week 0 (Baseline), Week 52 (Endpoint, LOCF) ] [ Designated as safety issue: No ]
    The ABC is an informant-based symptom checklist for assessing and classifying 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 and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Irritability Subscale Score is from 0 to 45. A negative change signifies improvement

  • Mean Change From Baseline in ABC Hyperactivity Subscale Score at Week 52 (Endpoint, LOCF) [ Time Frame: Week 0 (Baseline), Week 52 (Endpoint, LOCF) ] [ Designated as safety issue: No ]
    The ABC is an informant-based symptom checklist for assessing and classifying 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 and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Hyperactivity Subscale Score is from 0 to 48. A negative change score signifies improvement.

  • Change From Baseline in ABC Stereotypy Subscale Score at Week 52 (Endpoint, LOCF) [ Time Frame: Week 0 (Baseline), Week 52 (Endpoint, LOCF) ] [ Designated as safety issue: No ]
    The ABC is an informant-based symptom checklist for assessing and classifying 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 and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Stereotypy Subscale Score is from 0 to 21. A negative change score signifies improvement.

  • Mean Change From Baseline in ABC Social Withdrawal Scale At Week 52 (Endpoint, LOCF) [ Time Frame: Week 0 (Baseline), Week 52 (Endpoint, LOCF) ] [ Designated as safety issue: No ]
    The ABC is an informant-based symptom checklist for assessing and classifying 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 and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Social Withdrawal Subscale Score is from 0 to 48. A negative change score signifies improvement.

  • Mean Change From Baseline in ABC Inappropriate Speech Subscale Score at Week 52 (Endpoint, LOCF) [ Time Frame: Week 0 (Baseline), Week 52 (Endpoint, LOCF) ] [ Designated as safety issue: No ]
    The ABC is an informant-based symptom checklist for assessing and classifying 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 and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Inappropriate Speech Subscale score is from 1 to 12. A negative change score signifies improvement.

  • Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Score at Week 52 (Endpoint, LOCF) [ Time Frame: Week 0 (Baseline), Week 52 (Endpoint, LOCF) ] [ Designated as safety issue: No ]
    CY-BOCS is a 10-item, clinician-rated scale designed to measure the severity of obsessive-compulsive symptoms in patients below the age of 18. The scale contains 5 items pertaining to obsessions (which were not used in this trial) and 5 items pertaining to compulsions, which rated each symptom domain in terms of time spent, interference with functioning, distress, resistance, and control. Each item was rated on a 5-point scale, from 0 (no symptoms or minimum severity) to 4 (extreme symptoms or maximum severity). CY-BOCS Score is from 0 to 20. A negative change score signifies improvement.


Enrollment: 330
Study Start Date: September 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: De Novo
De novo participants (those who did not participate in protocol (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]) assigned to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
Drug: Aripiprazole
Tablets, Oral, 2, 5, 10, or 15 mg, once daily, 52 weeks
Other Names:
  • Abilify
  • BMS-337039
Experimental: Rollover Placebo
Participants who completed participation in protocol (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]) on placebo treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
Drug: Aripiprazole
Tablets, Oral, 2, 5, 10, or 15 mg, once daily, 52 weeks
Other Names:
  • Abilify
  • BMS-337039
Experimental: Rollover Aripiprazole
Participants who completed participation in protocol CN138-178 [NCT00332241] or CN138-179 [NCT00337571] on aripiprazole treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
Drug: Aripiprazole
Tablets, Oral, 2, 5, 10, or 15 mg, once daily, 52 weeks
Other Names:
  • Abilify
  • BMS-337039

  Eligibility

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

Inclusion Criteria - Rollover:

  • Completed 8 weeks of treatment in one of the following double-blind clinical trials: CN138-178 [NCT00332241] or CN138-179 [NCT00337571]
  • No significant protocol violations and sufficient medical justification to continue on open-label treatment with aripiprazole

Inclusion Criteria - De Novo:

  • Meets current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) diagnostic criteria for AD and demonstrates serious behavioral problems - diagnosis confirmed by Autism Diagnostic Interview-Revised (ADI-R) or the patient meets the current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) diagnostic criteria for AD and has a history of behavioral problems that are currently being treated with psychotropic medication
  • Mental age of at least 18 months
  • Male or female 6 to 17 years of age, inclusive, at the time of enrollment

Exclusion Criteria:

  • Patients considered treatment resistant to neuroleptic medication based on lack of therapeutic response to 2 different neuroleptics after treatment of at least 3 weeks each
  • Patients previously treated and not responding to aripiprazole treatment
  • The patient is currently diagnosed with another disorder on the autism spectrum, including pervasive developmental disorder-not otherwise specified (PDD-NOS), Asperger's Disorder, Rett's Disorder, Fragile-X Syndrome or Childhood Disintegrative Disorder
  • Current diagnosis of bipolar disorder, psychosis, schizophrenia, or major depression
  • A seizure in the past year
  • History of severe head trauma or stroke
  • Non-pharmacologic therapy (e.g. psychotherapy, behavior modification) should be stable prior to screening and consistent throughout the study
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365859

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35203
Harmonex Neuroscience
Dothan, Alabama, United States, 36303
United States, Arizona
Southwest Autism Research and Resource Center
Phoenix, Arizona, United States, 85006
Univ of Arizona
Tuscon, Arizona, United States, 85724-5002
United States, California
Clinical Innovations, Inc
Costa Mesa, California, United States, 92626
Peninsula Research Assoc
Rolling Hills Estate, California, United States, 90274
University Of California-Davis Health Science Center
Sacramento, California, United States, 95817
Sharp Mesa Vista Hospital
San Diego, California, United States, 92123
Stanford University School Of Medicine
Stanford, California, United States, 94305-5719
United States, Colorado
The Children's Hospital
Aurora, Colorado, United States, 80045
United States, Florida
Offices of Gregory Marsella, MD, PA
Boca Raton, Florida, United States, 33432
University of Florida
Gainesville, Florida, United States, 32611
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607
Miami Children's Hospital
Miami, Florida, United States, 33155
University of South Florida
Tampa, Florida, United States, 33613
Children's Developmental Center
Winter Park, Florida, United States, 32792
United States, Georgia
Child Neurology Associates, PC
Atlanta, Georgia, United States, 30342
Institute For Behavioral Medicine
Smyrna, Georgia, United States, 30080-6342
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60608
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Cambridge Health Alliance
Cambridge, Massachusetts, United States, 02139
Ladders Clinic
Wellsley, Massachusetts, United States, 02481
United States, Michigan
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, United States, 48302
Children's Hospital Of Michigan
Detroit, Michigan, United States, 48201
United States, Minnesota
Regions Hospital
St. Paul, Minnesota, United States, 55101
United States, Missouri
Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States, 64108-4619
United States, Nebraska
Munroe-Meyer Institute Diagnostic Center
Omaha, Nebraska, United States, 68198-5380
United States, Nevada
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Children's Specialized Hospital
Toms River, New Jersey, United States, 08755
United States, New York
North Shore - Long Island Jewish Health System
Bethpage, New York, United States, 11714
Seaver and New York Autism Center of Excellence
New York, New York, United States, 10029
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
SUNY at Stony Brook - School of Medicine
Stony Brook, New York, United States, 11794-8790
United States, North Carolina
Mission Hospitals - Mission Children's Clinics
Asheville, North Carolina, United States, 22801
University of NC
Chapel Hill, North Carolina, United States, 27599-7160
Duke Child and Family Study Center
Durham, North Carolina, United States, 27710
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0559
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
The Nisonger Center
Columbus, Ohio, United States, 43210
United States, Oklahoma
Cutting Edge Research
Oklahoma City, Oklahoma, United States, 73116
United States, Pennsylvania
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15203
United States, Tennessee
UT Medical Group, Department Of Psychiatry
Memphis, Tennessee, United States, 38105
United States, Texas
Dallas Pediatric Neurology Associates
Dallas, Texas, United States, 75230
Bayou City Research, Ltd.
Houston, Texas, United States, 77007
Red Oak Psychiatry Associates, PA
Houston, Texas, United States, 77090
North San Antonio Healthcare Associates
San Antonio, Texas, United States, 78218
United States, Virginia
Children's National Medical Center
Fairfax, Virginia, United States, 22031
Neuroscience, Inc
Herndon, Virginia, United States, 20170
Monarch Research Associates
Norfolk, Virginia, United States, 23510
Virginia Treatment Center For Children
Richmond, Virginia, United States, 23298
United States, Washington
Pacific Institute of Medical Sciences
Bothell, Washington, United States, 98034
Autism Spectrum Treatment and Research Center
Seattle, Washington, United States, 98109
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Otsuka Pharmaceutical Development & Commercialization, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00365859     History of Changes
Other Study ID Numbers: CN138-180
Study First Received: August 15, 2006
Results First Received: December 17, 2009
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Serious behavioral problems in children and adolescents with AD
behavioral problems

Additional relevant MeSH terms:
Autistic Disorder
Behavioral Symptoms
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Aripiprazole
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 September 15, 2014