Clinical trial NCT00337571: Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Behavioral Symptoms
Autistic Disorder
Keywords: Serious behavioral problems in children and adolescents with AD
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2006-06-16
Enrollment: 218
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score
timeFrame: Week 8
Secondary outcomes:
measure: Mean Clinical Global Impressions Improvement Scale (CGI-I) Score
timeFrame: Week 8
measure: Number of Participants With Response at Week 8
timeFrame: Week 8
measure: Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)
timeFrame: Week 8
measure: Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores
timeFrame: Week 8
measure: Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)
timeFrame: Week 8
measure: Summary of Safety
timeFrame: continuously throughout the study
measure: Change From Baseline in Body Weight
timeFrame: Week 8
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama At Birmingham
state: Alabama
city: Dothan
country: United States
facility: Harmonex Neuroscience
state: Alabama
city: Phoenix
country: United States
facility: Southwest Autism Research And Resource Center
state: Arizona
city: Huntington Beach
country: United States
facility: Clinical Innovations, Inc.
state: California
city: Sacramento
country: United States
facility: University Of California-Davis Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University School Of Medicine
state: California
city: Aurora
country: United States
facility: The Children'S Hospital
state: Colorado
city: Boca Raton
country: United States
facility: Marsella, Gregory
state: Florida
city: Gainesville
country: United States
facility: University Of Florida
state: Florida
city: Tampa
country: United States
facility: University Of South Florida
state: Florida
city: Smyrna
country: United States
facility: Institute For Behavioral Medicine
state: Georgia
city: Chicago
country: United States
facility: University Of Illinois At Chicago
state: Illinois
city: Medford
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
city: Wellsley
country: United States
facility: Ladders Clinic
state: Massachusetts
city: Detroit
country: United States
facility: Children'S Hospital Of Michigan
state: Michigan
city: St. Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Kansas City
country: United States
facility: Children'S Mercy Hospital
state: Missouri
city: Omaha
country: United States
facility: Munroe-Meyer Institute
state: Nebraska
city: Bethpage
country: United States
facility: North Shore - Long Island Jewish Health System
state: New York
city: New York
country: United States
facility: Seaver And New York Autism Center Of Excellence
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Asheville
country: United States
facility: Mission Hospitals
state: North Carolina
city: Durham
country: United States
facility: Duke Child And Family Study Center
state: North Carolina
city: Columbus
country: United States
facility: The Nisonger Center
state: Ohio
city: Oklahoma City
country: United States
facility: Cutting Edge Research
state: Oklahoma
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute And Clinic
state: Pennsylvania
city: Dallas
country: United States
facility: Dallas Pediatric Neurology Associates
state: Texas
city: Houston
country: United States
facility: Bayou City Research, Ltd.
state: Texas
city: Fairfax
country: United States
facility: Children'S National Medical Center
state: Virginia
city: Bothell
country: United States
facility: Pacific Institute Of Medical Sciences
state: Washington
city: Milwaukee
country: United States
facility: Children'S Hospital Of Wisconsin
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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):1110-1119. doi: 10.1097/CHI.0b013e3181b76658.
citation: 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.
citation: 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.