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, Flexible-Dosed, Parallel-Group Study of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder (AD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332241
• Other study ID #: CN138-178
• Status: Completed
• Phase: Phase 3
• First received: May 31, 2006
• Last updated: November 7, 2013
• Start date: June 2006
• Est. completion date: April 2008

Study information

• Verified date: December 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, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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 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

Intervention

Drug:
• Aripiprazole
Tablets, Oral, 5, 10, or 15 mg, once daily, 8 weeks
• Placebo
Tablets, Oral, once daily, 8 weeks

Locations

Country	Name	City	State
United States	Child Neurology Associates, Pc	Atlanta	Georgia
United States	Neurobehavioral Medicine Group	Bloomfield Hills	Michigan
United States	Marsella, Gregory	Boca Raton	Florida
United States	Univ Of Nc	Chapel Hill	North Carolina
United States	Red Oak Psychiatry Associates, Pa	Houston	Texas
United States	Center For Psychiatry And Behavioral Medicine	Las Vegas	Nevada
United States	University Of Louisville	Louisville	Kentucky
United States	Ut Medical Group	Memphis	Tennessee
United States	Suny - Stony Brook School Of Medicine	Stony Brook	New York

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — 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 decrease 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	continuous 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