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

Autistic Disorder Clinical Trial

Official title:

A Multicenter Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study With Three Fixed Doses of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00337571
• Other study ID #: CN138-179
• Status: Completed
• Phase: Phase 3
• First received: June 13, 2006
• Last updated: November 7, 2013
• Start date: June 2006
• Est. completion date: June 2008

Study information

• Verified date: November 2009
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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).

• CGI score > = 4 AND an 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, 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autistic Disorder
• Behavioral Symptoms

Intervention

Drug:
• Aripiprazole
Tablets, Oral, once daily, 8 weeks
• Placebo
Tablets, Oral, once daily, 8 weeks

Locations

Country	Name	City	State
United States	Mission Hospitals	Asheville	North Carolina
United States	The Children'S Hospital	Aurora	Colorado
United States	North Shore - Long Island Jewish Health System	Bethpage	New York
United States	University Of Alabama At Birmingham	Birmingham	Alabama
United States	Marsella, Gregory	Boca Raton	Florida
United States	Pacific Institute Of Medical Sciences	Bothell	Washington
United States	University Of Illinois At Chicago	Chicago	Illinois
United States	The Nisonger Center	Columbus	Ohio
United States	Dallas Pediatric Neurology Associates	Dallas	Texas
United States	Children'S Hospital Of Michigan	Detroit	Michigan
United States	Harmonex Neuroscience	Dothan	Alabama
United States	Duke Child And Family Study Center	Durham	North Carolina
United States	Children'S National Medical Center	Fairfax	Virginia
United States	University Of Florida	Gainesville	Florida
United States	Bayou City Research, Ltd.	Houston	Texas
United States	Clinical Innovations, Inc.	Huntington Beach	California
United States	Children'S Mercy Hospital	Kansas City	Missouri
United States	Cambridge Health Alliance	Medford	Massachusetts
United States	Children'S Hospital Of Wisconsin	Milwaukee	Wisconsin
United States	Seaver And New York Autism Center Of Excellence	New York	New York
United States	Cutting Edge Research	Oklahoma City	Oklahoma
United States	Munroe-Meyer Institute	Omaha	Nebraska
United States	Southwest Autism Research And Resource Center	Phoenix	Arizona
United States	Western Psychiatric Institute And Clinic	Pittsburgh	Pennsylvania
United States	University Of California-Davis Medical Center	Sacramento	California
United States	Institute For Behavioral Medicine	Smyrna	Georgia
United States	Regions Hospital	St. Paul	Minnesota
United States	Stanford University School Of Medicine	Stanford	California
United States	Richmond Behavioral Associates	Staten Island	New York
United States	University Of South Florida	Tampa	Florida
United States	Ladders Clinic	Wellsley	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka America Pharmaceutical

Country where clinical trial is conducted

United States, 

References & Publications (1)

Marcus RN, Owen R, Kamen L, Manos G, McQuade RD, Carson WH, Aman MG. A placebo-controlled, fixed-dose study of aripiprazole in children and adolescents with irritability associated with autistic disorder. J Am Acad Child Adolesc Psychiatry. 2009 Nov;48(11):1110-9. doi: 10.1097/CHI.0b013e3181b76658. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score	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	No
Secondary	Mean Clinical Global Impressions Improvement Scale (CGI-I) Score	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	No
Secondary	Number of Participants With Response at 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	No
Secondary	Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)	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 decreased in value indicates improvement.	Week 8	No
Secondary	Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores	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	No
Secondary	Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)	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	No
Secondary	Summary of Safety	Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation	continuously throughout the study	Yes
Secondary	Change From Baseline in Body Weight	Adjusted mean change (Week 8 - baseline) in body weight	Week 8	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm