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

Primary Purpose

Autistic Disorder, Behavioral Symptoms

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Aripiprazole

About this trial

This is an interventional treatment trial for Autistic Disorder focused on measuring Serious behavioral problems in children and adolescents with AD, behavioral problems

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

De Novo

Rollover Placebo

Rollover Aripiprazole

Arm Description

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.

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.

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.

Outcomes

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

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

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

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

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

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

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

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

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

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

Mean Change From Baseline by Time Period in Body Weight Z-Score

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)

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

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)

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)

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)

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)

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)

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)

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)

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)

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.

Full Information

NCT ID

NCT00365859

First Posted

August 15, 2006

Last Updated

November 7, 2013

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Otsuka America Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT00365859

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Otsuka America Pharmaceutical

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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]).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autistic Disorder, Behavioral Symptoms

Keywords

Serious behavioral problems in children and adolescents with AD, behavioral problems

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

330 (Actual)

8. Arms, Groups, and Interventions

Arm Title

De Novo

Arm Type

Experimental

Arm Description

Arm Title

Rollover Placebo

Arm Type

Experimental

Arm Description

Arm Title

Rollover Aripiprazole

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Aripiprazole

Other Intervention Name(s)

Abilify, BMS-337039

Intervention Description

Tablets, Oral, 2, 5, 10, or 15 mg, once daily, 52 weeks

Primary Outcome Measure Information:

Title

Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs

Description

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

Title

Mean Change From Baseline in Total Simpson-Angus Scale (SAS) At Week 8, Week 26, and Week 52

Description

Time Frame

Baseline, Week 8, Week 26, Week 52

Title

Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) At Week 8, Week 26, and Week 52

Description

Time Frame

Baseline, Week 8, Week 26, Week 52

Title

Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Week 8, Week 26, Week 52, and Endpoint

Description

Time Frame

Baseline, Week 8, Week 26, Week 52

Title

Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities

Description

Time Frame

At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52

Title

Number of Participants With Potentially Clinically Relevant Laboratory Hematology Abnormalities

Description

Time Frame

At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52

Title

Number of Participants With Potentially Clinically Relevant Laboratory Chemistry Abnormalities

Description

Time Frame

At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52

Title

Number of Participants With Potentially Clinically Relevant Eletrocardiograph (ECG) Abnormalities

Description

Time Frame

At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52

Title

Number of Potentially Clinically Relevant Vital Sign Abnormalities

Description

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)

Title

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)

Title

Mean Change From Baseline by Time Period in Body Weight Z-Score

Description

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)

Title

Mean Change From Baseline in Patient Body Mass Index (BMI)

Description

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)

Title

Mean Change From Baseline By Time Period in BMI Z-Score

Description

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)

Secondary Outcome Measure Information:

Title

Mean Change From Baseline in Clinical Global Impression (CGI)-Severity Score at Week 52 (Endpoint, LOCF)

Description

Time Frame

Week 0 (Baseline), Week 52 (Endpoint, LOCF)

Title

CGI-Improvement Score at Week 52 (Endpoint, LOCF)

Description

Time Frame

Week 52 (Endpoint, LOCF)

Title

Mean Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Score at Week 52 (Endpoint, LOCF)

Description

Time Frame

Week 0 (Baseline), Week 52 (Endpoint, LOCF)

Title

Mean Change From Baseline in ABC Hyperactivity Subscale Score at Week 52 (Endpoint, LOCF)

Description

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.

Time Frame

Week 0 (Baseline), Week 52 (Endpoint, LOCF)

Title

Change From Baseline in ABC Stereotypy Subscale Score at Week 52 (Endpoint, LOCF)

Description

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.

Time Frame

Week 0 (Baseline), Week 52 (Endpoint, LOCF)

Title

Mean Change From Baseline in ABC Social Withdrawal Scale At Week 52 (Endpoint, LOCF)

Description

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.

Time Frame

Week 0 (Baseline), Week 52 (Endpoint, LOCF)

Title

Mean Change From Baseline in ABC Inappropriate Speech Subscale Score at Week 52 (Endpoint, LOCF)

Description

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.

Time Frame

Week 0 (Baseline), Week 52 (Endpoint, LOCF)

Title

Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Score at Week 52 (Endpoint, LOCF)

Description

Time Frame

Week 0 (Baseline), Week 52 (Endpoint, LOCF)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35203

Country

United States

Facility Name

Harmonex Neuroscience

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36303

Country

United States

Facility Name

Southwest Autism Research and Resource Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

Facility Name

Univ of Arizona

City

Tuscon

State/Province

Arizona

ZIP/Postal Code

85724-5002

Country

United States

Facility Name

Clinical Innovations, Inc

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92626

Country

United States

Facility Name

Peninsula Research Assoc

City

Rolling Hills Estate

State/Province

California

ZIP/Postal Code

90274

Country

United States

Facility Name

University Of California-Davis Health Science Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Sharp Mesa Vista Hospital

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Stanford University School Of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305-5719

Country

United States

Facility Name

The Children's Hospital

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Offices of Gregory Marsella, MD, PA

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33432

Country

United States

Facility Name

Sarkis Clinical Trials

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32611

Country

United States

Facility Name

Miami Children's Hospital

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

University of South Florida

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Children's Developmental Center

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32792

Country

United States

Facility Name

Child Neurology Associates, PC

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Institute For Behavioral Medicine

City

Smyrna

State/Province

Georgia

ZIP/Postal Code

30080-6342

Country

United States

Facility Name

University of Illinois at Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60608

Country

United States

Facility Name

Kansas University Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

University of Louisville

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Massachusetts General Hospital

City

Cambridge

State/Province

Massachusetts

ZIP/Postal Code

02138

Country

United States

Facility Name

Cambridge Health Alliance

City

Cambridge

State/Province

Massachusetts

ZIP/Postal Code

02139

Country

United States

Facility Name

Ladders Clinic

City

Wellsley

State/Province

Massachusetts

ZIP/Postal Code

02481

Country

United States

Facility Name

Neurobehavioral Medicine Group

City

Bloomfield Hills

State/Province

Michigan

ZIP/Postal Code

48302

Country

United States

Facility Name

Children's Hospital Of Michigan

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Regions Hospital

City

St. Paul

State/Province

Minnesota

ZIP/Postal Code

55101

Country

United States

Facility Name

Children's Mercy Hospital and Clinics

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64108-4619

Country

United States

Facility Name

Munroe-Meyer Institute Diagnostic Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198-5380

Country

United States

Facility Name

Center for Psychiatry and Behavioral Medicine

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

Children's Specialized Hospital

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08755

Country

United States

Facility Name

North Shore - Long Island Jewish Health System

City

Bethpage

State/Province

New York

ZIP/Postal Code

11714

Country

United States

Facility Name

Seaver and New York Autism Center of Excellence

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Richmond Behavioral Associates

City

Staten Island

State/Province

New York

ZIP/Postal Code

10312

Country

United States

Facility Name

SUNY at Stony Brook - School of Medicine

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794-8790

Country

United States

Facility Name

Mission Hospitals - Mission Children's Clinics

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

22801

Country

United States

Facility Name

University of NC

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599-7160

Country

United States

Facility Name

Duke Child and Family Study Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

University of Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267-0559

Country

United States

Facility Name

University Hospitals of Cleveland

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

The Nisonger Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Cutting Edge Research

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73116

Country

United States

Facility Name

Western Psychiatric Institute and Clinic

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15203

Country

United States

Facility Name

UT Medical Group, Department Of Psychiatry

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38105

Country

United States

Facility Name

Dallas Pediatric Neurology Associates

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Bayou City Research, Ltd.

City

Houston

State/Province

Texas

ZIP/Postal Code

77007

Country

United States

Facility Name

Red Oak Psychiatry Associates, PA

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

North San Antonio Healthcare Associates

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78218

Country

United States

Facility Name

Children's National Medical Center

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22031

Country

United States

Facility Name

Neuroscience, Inc

City

Herndon

State/Province

Virginia

ZIP/Postal Code

20170

Country

United States

Facility Name

Monarch Research Associates

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23510

Country

United States

Facility Name

Virginia Treatment Center For Children

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Facility Name

Pacific Institute of Medical Sciences

City

Bothell

State/Province

Washington

ZIP/Postal Code

98034

Country

United States

Facility Name

Autism Spectrum Treatment and Research Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Children's Hospital of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21813076

Citation

Marcus RN, Owen R, Manos G, Mankoski R, Kamen L, McQuade RD, Carson WH, Findling RL. Safety and tolerability of aripiprazole for irritability in pediatric patients with autistic disorder: a 52-week, open-label, multicenter study. J Clin Psychiatry. 2011 Sep;72(9):1270-6. doi: 10.4088/JCP.09m05933. Epub 2011 Jul 26.

Results Reference

derived

PubMed Identifier

21663425

Citation

Marcus RN, Owen R, Manos G, Mankoski R, Kamen L, McQuade RD, Carson WH, Corey-Lisle PK, Aman MG. Aripiprazole in the treatment of irritability in pediatric patients (aged 6-17 years) with autistic disorder: results from a 52-week, open-label study. J Child Adolesc Psychopharmacol. 2011 Jun;21(3):229-36. doi: 10.1089/cap.2009.0121.

Results Reference

derived

Links:

URL

http://www.cdc.gov/growthcharts/percentile_data_files.htm

Description

Centers for Disease Control and Prevention (CDC) algorithm for BMI and body weight z-scores

Learn more about this trial

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

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

Autistic Disorder, Behavioral Symptoms

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial