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Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00870727
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.
Collaborators:
National Institute of Mental Health (NIMH)
Bristol-Myers Squibb
Information provided by (Responsible Party):
Indiana University
  Purpose
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.

Condition Intervention Phase
Pervasive Developmental Disorder Drug: Aripiprazole oral product Drug: Placebo oral capsule Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacotherapy of Pervasive Developmental Disorders

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Clinical Global Impression - Improvement [ Time Frame: At Baseline and Week 8 ]
  • Aberrant Behavior Checklist Irritability Scale [ Time Frame: At Baseline and Week 8 ]

Secondary Outcome Measures:
  • The Aberrant Behavior Checklist Lethargy, Stereotypy, Hyperactivity and Inappropriate Speech Subscales [ Time Frame: At Baseline and Week 8 ]

Enrollment: 33
Study Start Date: February 2009
Study Completion Date: May 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
Drug: Placebo oral capsule
Placebo will identical in size and appearance to study drug.
Other Name: Sugar pill

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00870727


Locations
United States, Massachusetts
Lurie Center
Lexington,, Massachusetts, United States, 02421
Sponsors and Collaborators
Indiana University
National Institute of Mental Health (NIMH)
Bristol-Myers Squibb
Investigators
Principal Investigator: Christopher J. McDougle, MD Harvard University
  More Information

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00870727     History of Changes
Other Study ID Numbers: 0805-26
MH 082119
First Submitted: February 2, 2009
First Posted: March 27, 2009
Last Update Posted: October 12, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Indiana University:
PDD NOS

Additional relevant MeSH terms:
Developmental Disabilities
Child Development Disorders, Pervasive
Disease
Autism Spectrum Disorder
Autistic Disorder
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs