Clinical trial NCT00332241: Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autistic Disorder
Keywords: Serious behavioral problems in children and adolescents with AD
Behavioral Problems
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2006-06-01
Enrollment: 98
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, flexibly dosed with a placebo, 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 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.

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: continuous throughout the study
measure: Change From Baseline in Body Weight
timeFrame: Week 8
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Marsella, Gregory
state: Florida
city: Atlanta
country: United States
facility: Child Neurology Associates, Pc
state: Georgia
city: Louisville
country: United States
facility: University Of Louisville
state: Kentucky
city: Bloomfield Hills
country: United States
facility: Neurobehavioral Medicine Group
state: Michigan
city: Las Vegas
country: United States
facility: Center For Psychiatry And Behavioral Medicine
state: Nevada
city: Stony Brook
country: United States
facility: Suny - Stony Brook School Of Medicine
state: New York
city: Chapel Hill
country: United States
facility: Univ Of Nc
state: North Carolina
city: Memphis
country: United States
facility: Ut Medical Group
state: Tennessee
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, Pa
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
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.
citation: 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.