Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders
Condition: Pervasive Developmental Disorder
MeSH terms: Developmental Disabilities; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Intervention: Aripiprazole oral product; Placebo oral capsule
Intervention description: Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.; Placebo will be identical in size and appearance to study drug.
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: PDD NOS

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 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.
    

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).