An Open-Label Trial of Aripiprazole in Autism Spectrum Disorders

NCT00308074 | Completed Phase 2 Results

• 1 other identifier: CHA-IRB-0119/06/05
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the efficacy, safety and tolerability of aripiprazole monotherapy in the treatment of children and adolescents suffering from Autism Spectrum Disorder (ASD) over a 12-week period. We hypothesize that aripiprazole may be helpful in reducing ASD-associated symptoms of anxiety and aggression, resulting in significant improvements in global outcome.

Conditions

Autism; Asperger's Disorder; Pervasive Developmental Disorder

Keywords

behavioral problems; aggression; autism; aripiprazole

Outcome Measures

Primary Outcomes (2)

• Clinical Global Impressions-Improvement

  The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to evaluate how much the patient's illness has improved or worsened compared to their baseline condition at the beginning of the intervention. The ratings are evaluated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.

  Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.

• Aberrant Behavior Checklist-Irritability Subscale

  Aberrant Behavior Checklist (ABC) The ABC is a 58 item symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. Items are rated on a 4-point scale (0=no problem to 3=severe problem). A decrease in score indicates improvement. There are five subscales: a) Irritability and Agitation b) Lethargy and Social Withdrawal c) Stereotypic Behavior d) Hyperactivity and Noncompliance and e) Inappropriate Speech.This study uses the Irritability subscale for its outcome. The Irritability subscale is the sum of 15 items. Each item is rated using the scale: 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The Irritability subscale total score ranges from 0 to 45. A decrease in score over time indicates improvement.

  Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.

Secondary Outcomes (2)

• Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

  Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.

• Brief Psychiatric Rating Scale for Children (BPRS-C)

  Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.

Study Arms (1)

Aripiprazole

EXPERIMENTAL

aripiprazole monotherapy, begun at 2.5 mg or 5.0 mg based on clinical impression and severity of aggression and agitation. Dose to be adjusted in not more than 5 mg increments, weekly. The lowest effective dose will be used up to a maximum daily dose of 20 mg.

Drug: Aripiprazole

Interventions

Aripiprazole DRUG

open-label, flexible-dosing

Also known as: Abilify

Aripiprazole

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males and Females ages 6-17
• A diagnosis of Autism, Asperger's Disorder, or Pervasive Developmental Disorder - not otherwise specified (PDD NOS)
• Medically healthy
• Ability to give assent
• Significant tantrums, aggression, self-injurious behavior and/or agitation by achieving a score of 18 or higher on the Aberrant Behavior Checklist-irritability subscale and a score of moderate or higher on the Clinical Global Impressions-Severity Scale.

You may not qualify if:

• Co-morbid serious mental illness.
• Intelligence Quotient (IQ) \<50, based on verified records of cognitive testing performed within 2 years of enrollment. In event that suitable records of prior testing are unavailable, IQ will be estimated using the Wechsler Abbreviated Scale of Intelligence (WASI, 1999 Harcourt Assessment, Inc.).
• Significant active medical and/or neurological illness.
• Subjects that require other psychotropic medications such as antidepressants, mood stabilizers, anticonvulsants, stimulants, sedatives, or other antipsychotic medications in order to maintain clinical stability.
• Active substance abuse/dependence based upon history and urine toxicology screen.
• Inability to have blood drawn at baseline and termination visits.
• Known allergy or hypersensitivity to aripiprazole or its ingredients.
• Patients clinically stable on current medications.

Sponsors & Collaborators

• Cambridge Health Alliance: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Cambridge Health Alliance

Medford, Massachusetts, 02155, United States

Location

Related Links

• Research program website

MeSH Terms

Conditions

Autistic Disorder; Asperger Syndrome; Child Development Disorders, Pervasive; Problem Behavior; Aggression

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Child Behavior; Aberrant Motor Behavior in Dementia; Social Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Jean A. Frazier
• Organization: University of Massachusetts Medical School

ChildResearch@umassmed.edu

508-856-5896

Study Officials

• Jean A Frazier, MD

  Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Child & Adolescent Neuropsychiatric Research Program

Study Record Dates

• First Submitted: March 28, 2006
• First Posted: March 29, 2006
• Study Start: February 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: February 1, 2009
• Last Updated: February 15, 2017
• Results First Posted: January 2, 2017

Record last verified: 2016-12

Locations

US (1)