NCT00332241

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 23, 2009

Completed
Last Updated

May 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

May 31, 2006

Results QC Date

June 3, 2009

Last Update Submit

April 23, 2026

Conditions

Autistic Disorder

Keywords

Serious behavioral problems in children and adolescents with ADBehavioral Problems

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Mean Clinical Global Impressions Improvement Scale (CGI-I) Score

    Week 8

  • Number of Participants With Response at Week 8

    Week 8

  • Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)

    Week 8

  • Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores

    Week 8

  • Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)

    Week 8

  • +2 more secondary outcomes

Study Arms (2)

A1

EXPERIMENTAL

Active Abilify

Drug: Aripiprazole

A2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AripiprazoleDRUG

Tablets, Oral, 5, 10, or 15 mg, once daily, 8 weeks

Also known as: Abilify
A1
PlaceboDRUG

Tablets, Oral, once daily, 8 weeks

A2

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Marsella, Gregory

Boca Raton, Florida, 33432, United States

Location

Child Neurology Associates, Pc

Atlanta, Georgia, 30342, United States

Location

University Of Louisville

Louisville, Kentucky, 40202, United States

Location

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, 48302, United States

Location

Center For Psychiatry And Behavioral Medicine

Las Vegas, Nevada, 89128, United States

Location

Suny - Stony Brook School Of Medicine

Stony Brook, New York, 11794, United States

Location

Univ Of Nc

Chapel Hill, North Carolina, 27599, United States

Location

Ut Medical Group

Memphis, Tennessee, 38105, United States

Location

Red Oak Psychiatry Associates, Pa

Houston, Texas, 77090, United States

Location

Related Publications (4)

  • 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.

    PMID: 19948625BACKGROUND

  • 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.

    PMID: 24138011DERIVED

  • 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.

    PMID: 21731831DERIVED

  • 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.

    PMID: 20973712DERIVED

Related Links

MeSH Terms

Conditions

Autistic DisorderProblem Behavior

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavioral SymptomsBehaviorChild Behavior

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Clinical Transparency
Organization
Otsuka
SMB_ClinicalTranspa@otsuka-us.com
1-800-441-6763

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2006

First Posted

June 1, 2006

Study Start

June 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

May 13, 2026

Results First Posted

July 23, 2009

Record last verified: 2026-04

Locations

US(9)