- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00332241
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
November 7, 2013 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.
A Multicenter Double-Blind, Randomized, Placebo-Controlled, Flexible-Dosed, Parallel-Group Study of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder (AD)
This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
98
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
-
Boca Raton, Florida, United States, 33432
- Marsella, Gregory
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Georgia
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Atlanta, Georgia, United States, 30342
- Child Neurology Associates, PC
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Kentucky
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Louisville, Kentucky, United States, 40202
- University of Louisville
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Michigan
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Bloomfield Hills, Michigan, United States, 48302
- Neurobehavioral Medicine Group
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Nevada
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Las Vegas, Nevada, United States, 89128
- Center for Psychiatry and Behavioral Medicine
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-
New York
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Stony Brook, New York, United States, 11794
- SUNY - Stony Brook School of Medicine
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Univ Of Nc
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Tennessee
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Memphis, Tennessee, United States, 38105
- UT Medical Group
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Texas
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Houston, Texas, United States, 77090
- Red Oak Psychiatry Associates, PA
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Meets current Diagnostic and Statistical Manual for Mental Disorders-Fourth Edition (DSM-IV) diagnostic criteria for AD and demonstrates serious behavioral problems. Diagnosis confirmed by Autism Diagnostic Interview- Revised (ADI-R)
- CGI score > = 4 AND and Aberrant Behavior Checklist (ABC) Irritability/Agitation subscale score > = 18 at screening and baseline (randomization)
- Mental age of at least 18 months
- Male or female 6 to 17 years of age, inclusive, at the time of randomization
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 PDD-NOS, Asperger's Disorder, Rett's Disorder, Fragile-X Syndrome or Childhood Disintegrative Disorder
- Current diagnosis of bipolar disorder, psychosis, or schizophrenia, or major depression
- A seizure in the past year
- History of severe head trauma or stroke
- Patients undergoing non-pharmacologic therapies (e.g., psychotherapy, behavioral modification) must have started at least 2 months prior to the initial screening visit and must remain in a consistent treatment program for the duration of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: A2
|
Tablets, Oral, once daily, 8 weeks
|
Experimental: A1
Active Abilify
|
Tablets, Oral, 5, 10, or 15 mg, once daily, 8 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score
Time Frame: Week 8
|
The ABC is a 58-item informant-based assessment of problem behaviors in children/adolescents with mental retardation.
Items are rated on a 4-point scale (0=no problem, 3=severe problem), and resolve into 5 domain subscales.
A decrease in score indicates improvement.
|
Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Clinical Global Impressions Improvement Scale (CGI-I) Score
Time Frame: Week 8
|
The CGI scale is a clinician-rated global assessment of a patient's improvement over time.
Baseline assessment rated a patient's condition on a 7-point scale (1=no symptoms, 7=very severe symptoms).
Subsequent assessed improvement relative to baseline symptoms on a 7-point CGI-I item scale (1=very much improved, 7=very much worse).
|
Week 8
|
Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)
Time Frame: Week 8
|
A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=no symptoms; 7=very severe symptoms).
The patient's improvement relative to the symptoms at baseline on were assessed on a 7-point CGI-I (1=very much improved; 7=very much worse).
A decrease in value indicates improvement.
|
Week 8
|
Change From Baseline in Body Weight
Time Frame: Week 8
|
Adjusted mean change (Week 8 - baseline) in body weight
|
Week 8
|
Number of Participants With Response at Week 8
Time Frame: Week 8
|
Response defined as a ≥ 25% reduction from baseline to endpoint in the ABC Irritability Subscale score and a CGI-I score of 1 or 2 at endpoint
|
Week 8
|
Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)
Time Frame: Week 8
|
CY-BOCS=10-item assessment of obsessive-compulsive symptoms in patients <18 years.
5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale (0=no symptoms/minimum severity, 4=extreme symptoms/maximum severity).
A decrease in value indicates improvement.
|
Week 8
|
Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores
Time Frame: Week 8
|
Mean change (Week 8 - baseline) in the other ABC subscale scores (lethargy/social withdrawal; stereotypic behavior; hyperactivity/ noncompliance; inappropriate speech).
A decrease in value indicates improvement
|
Week 8
|
Summary of Safety
Time Frame: continuous throughout the study
|
Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation
|
continuous throughout the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mankoski R, Stockton G, Manos G, Marler S, McQuade R, Forbes RA, Marcus R. Aripiprazole treatment of irritability associated with autistic disorder and the relationship between prior antipsychotic exposure, adverse events, and weight change. J Child Adolesc Psychopharmacol. 2013 Oct;23(8):572-6. doi: 10.1089/cap.2012.0075.
- Robb AS, Andersson C, Bellocchio EE, Manos G, Rojas-Fernandez C, Mathew S, Marcus R, Owen R, Mankoski R. Safety and tolerability of aripiprazole in the treatment of irritability associated with autistic disorder in pediatric subjects (6-17 years old):results from a pooled analysis of 2 studies. Prim Care Companion CNS Disord. 2011;13(1):PCC.10m01008. doi: 10.4088/PCC.10m01008gry.
- Owen R, Sikich L, Marcus RN, Corey-Lisle P, Manos G, McQuade RD, Carson WH, Findling RL. Aripiprazole in the treatment of irritability in children and adolescents with autistic disorder. Pediatrics. 2009 Dec;124(6):1533-40. doi: 10.1542/peds.2008-3782.
- Aman MG, Kasper W, Manos G, Mathew S, Marcus R, Owen R, Mankoski R. Line-item analysis of the Aberrant Behavior Checklist: results from two studies of aripiprazole in the treatment of irritability associated with autistic disorder. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):415-22. doi: 10.1089/cap.2009.0120.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
May 31, 2006
First Submitted That Met QC Criteria
May 31, 2006
First Posted (Estimate)
June 1, 2006
Study Record Updates
Last Update Posted (Estimate)
December 2, 2013
Last Update Submitted That Met QC Criteria
November 7, 2013
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Neurodevelopmental Disorders
- Child Development Disorders, Pervasive
- Autism Spectrum Disorder
- Autistic Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Aripiprazole
Other Study ID Numbers
- CN138-178
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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