Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT00870727
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
17 Years
Study:
NCT00870727
Study Brief:
Protocol Section:
NCT00870727