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An Open-Label Trial of Aripiprazole in Autism Spectrum Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00308074
Recruitment Status : Completed
First Posted : March 29, 2006
Results First Posted : January 2, 2017
Last Update Posted : February 15, 2017
Bristol-Myers Squibb
Information provided by (Responsible Party):
Jean Frazier, Cambridge Health Alliance

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.

Condition or disease Intervention/treatment Phase
Autism Asperger's Disorder Pervasive Developmental Disorder Drug: Aripiprazole Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Open-Label Trial of Aripiprazole Monotherapy in the Autism Spectrum Disorders (ASD)
Study Start Date : February 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Aripiprazole
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
open-label, flexible-dosing
Other Name: Abilify

Primary Outcome Measures :
  1. Clinical Global Impressions-Improvement [ Time Frame: Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13. ]
    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.

  2. Aberrant Behavior Checklist-Irritability Subscale [ Time Frame: Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13. ]

    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.

Secondary Outcome Measures :
  1. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13. ]
    10-item assessment of obsessive-compulsive symptoms in patients less than 18 years of age. There are 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale ( from 0=no symptoms/minimum severity, to 4=extreme symptoms/maximum severity). Total is the sum of 10 items. The range of possible totals is 0 (no symptoms) to 40 (severe). A decrease in value indicates improvement.

  2. Brief Psychiatric Rating Scale for Children (BPRS-C) [ Time Frame: Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13. ]
    The Brief Psychiatric Rating Scale for Children is a 21-item rating scale to evaluate psychiatric problems based on the clinician' s interview with the child/adolescent and parents. It has 7 scales: behavioral problems, depression, thought disorders, psychomotor excitation, withdrawal-retardation, anxiety, organicity. Ratings are based on a 7 point scale, from "Not Present" (scores 0) to "Extremely Severe" (scores 6 points). Total is the sum of the 21 items. The range of possible totals is 0 (no symptoms) to 126 (extremely severe).A decrease in score indicates improvement.

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00308074

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United States, Massachusetts
Cambridge Health Alliance
Medford, Massachusetts, United States, 02155
Sponsors and Collaborators
Cambridge Health Alliance
Bristol-Myers Squibb
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Principal Investigator: Jean A Frazier, MD Cambridge Health Alliance
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Responsible Party: Jean Frazier, Director, Child & Adolescent Neuropsychiatric Research Program, Cambridge Health Alliance Identifier: NCT00308074    
Other Study ID Numbers: CHA-IRB-0119/06/05
First Posted: March 29, 2006    Key Record Dates
Results First Posted: January 2, 2017
Last Update Posted: February 15, 2017
Last Verified: December 2016
Keywords provided by Jean Frazier, Cambridge Health Alliance:
behavioral problems
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Developmental Disabilities
Asperger Syndrome
Pathologic Processes
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists