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Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 27, 2009
Last Update Posted: October 12, 2017
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.
National Institute of Mental Health (NIMH)
Bristol-Myers Squibb
Information provided by (Responsible Party):
Indiana University
February 2, 2009
March 27, 2009
October 12, 2017
February 2009
March 2015   (Final data collection date for primary outcome measure)
  • Clinical Global Impression - Improvement [ Time Frame: At Baseline and Week 8 ]
  • Aberrant Behavior Checklist Irritability Scale [ Time Frame: At Baseline and Week 8 ]
Same as current
Complete list of historical versions of study NCT00870727 on ClinicalTrials.gov Archive Site
The Aberrant Behavior Checklist Lethargy, Stereotypy, Hyperactivity and Inappropriate Speech Subscales [ Time Frame: At Baseline and Week 8 ]
Same as current
Not Provided
Not Provided
Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders
Pharmacotherapy of Pervasive Developmental Disorders
The purpose of this study is to develop a better tolerated and more effective pharmacologic treatment with individuals with Pervasive Developmental Disorder. This is a double-blind, placebo-controlled study of aripiprazole in the management of the maladaptive behaviors of Pervasive Developmental Disorder. The investigators hypothesize that aripiprazole will be more effective than placebo for reducing aggression,tantrum and self-injurious behavior in children with Pervasive Developmental Disorder.
Pervasive developmental disorders (PDD) are characterized by severe impairments in social interaction and communication in addition to restricted patterns of interests and activities. Research suggests that a dysregulation of the dopamine and serotonin systems contributes to these interfering behaviors in individuals with PDD. After benefits of typical neuroleptics were reported in subjects with PDD, research shifted to the atypical antipsychotic which have been shown to be better tolerated and effective in this population. However, the atypical antipsychotics have also been associated with adverse effects. Thus there remains a need for a novel pharmacotherapy that would be safe and effective for children and adolescents with PDD. The primary objectives of this study is to determine whether aripiprazole is effective and well tolerated for irritability in children and adolescents with PDD NOS during an 8-week acute phase and whether the effectiveness and tolerability of aripiprazole is maintained during a 16-week continuation phase.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Pervasive Developmental Disorder
  • Drug: Aripiprazole oral product
    Minimum dose of 2mg per day to a maximum of 20 mg per day over 8-weeks of treatment.
    Other Name: Abilify
  • Drug: Placebo oral capsule
    Placebo will identical in size and appearance to study drug.
    Other Name: Sugar pill
  • Experimental: Arm 1. Aripiprazole oral product
    Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.
    Intervention: Drug: Aripiprazole oral product
  • Placebo Comparator: Arm 2. Placebo oral capsule
    Partipants will recieve matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment.
    Intervention: Drug: Placebo oral capsule
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
May 2015
March 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female outpatients between the ages of 5 and 17 years and greater than or equal to 15kg body weight.
  • Diagnostic and Statistical Manual Fourth Edition, Text Revised (DSM-IV-TR) diagnosis of Pervasive Developmental Disorder Not Otherwise Specified (PDD NOS).
  • Psychotropic medication-free for at least 2 days prior to screening laboratory tests and electrocardiogram (ECG).
  • Significant irritability as determined by a Clinical Global Impression Severity of greater or equal to 4(Moderately ill)and a score of equal to or greater than 18 on the Aberrant Behavior Checklist Irritability Subscale.
  • Intelligence quotient (IQ) of equal to or greater than 50 based on the Wechsler Intelligence Scale for Children (WISC), 4th edition; Leiter International Test of Intelligence-Revised will be used if a child is nonverbal but thought to have an IQ greater than or equal to 50.

Exclusion Criteria:

  • DSM-IV-TR diagnosis other than PDD NOS (autism, Asperger's disorder, Rett's disorder, or childhood disintegrative disorder), schizophrenia, bipolar disorder or substance abuse within the last 6 months.
  • Comorbid disorder with possible association to autism (e.g., Fragile X Syndrome, Tuberous Sclerosis).
  • A significant medical condition such as heart, liver, renal, or pulmonary disease, or a seizure disorder, as determined by history, physical examination, or laboratory testing.
  • Subjects with an active seizure disorder (history of febrile seizures in early childhood will be considered.
  • Females with a positive urine pregnancy test.
  • Evidence of a prior adequate trial of aripiprazole (defined as equal to or greater than 2 weeks at equal to or greater than 5 mg per day. When there is not evidence of a prior adequate trial, subjects must be medication-free for a least 2 weeks prior to baseline.
  • History of neuroleptic malignant syndrome.
  • Subjects who, in the opinion of the investigator, are unsuitable in any other way to participate in this study, including being unable to comply with the requirements of the study for any reason.
  • Hypersensitivity to aripiprazole[e.g., allergic response or serious averse effect] (significant tachycardia)
Sexes Eligible for Study: All
5 Years to 17 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
MH 082119
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Indiana University
Indiana University
  • National Institute of Mental Health (NIMH)
  • Bristol-Myers Squibb
Principal Investigator: Christopher J. McDougle, MD Harvard University
Indiana University
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP