Status:
COMPLETED
Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Bristol-Myers Squibb
Conditions:
Pervasive Developmental Disorder
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
Pervasive developmental disorders (PDDs) are characterized by severe impairments in social interaction and communication in addition to restricted patterns of interests and activities. Research sugges...
Eligibility Criteria
Inclusion
- Male and female outpatients between the ages of 5 and 17 years and greater than or equal to 15 kg body weight.
- Diagnostic and Statistical Manual of Mental Disorders 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 score 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; the 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
- DSM-IV-TR diagnosis other than PDD NOS (autistic disorder, 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 \[e.g., allergic response or serious adverse effect\] (significant tachycardia).
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00870727
Start Date
February 1 2009
End Date
May 1 2015
Last Update
January 2 2019
Active Locations (1)
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1
Riley Hospital for Children, Christian Sarkine Autism Treatment Center
Indianapolis, Indiana, United States, 46202