Atomoxetine in children with pervasive developmental disorders.

1. Males and females between the ages of at least 6 years of age and not more than 17 years of age at visit 1;

2. ASD (DSM-IV TR diagnosis of autistic disorder or Asperger’s disorder or PDD not otherwise specified, established by clinical assessment and corroborated by Autism Diagnostic Interview scores;

3. Patients must score greater than 4 on the CGI-Severity with regard to ADHD symptoms and score at least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the ADHDRS-IV-Parent Version;

4. Outpatients;

5. Medication-free for at least two weeks for all psychotropic medications (four weeks for fluoxetine or neuroleptics);

6. IQ of at least 70;

7. Laboratory results, including serum chemistries, hematology, and urinalysis, show no significant abnormalities and there is no clinical information that, in the judgment of a physician, should preclude a patient’s participation at study entry;

8. Patients and parents (legal representative) have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venapunctures, and examinations required by the protocol. Patients must also be able to swallow capsules (study drug).

1. Patients who weigh less than 20 kg at study entry;

2. Females with a positive Beta HCG pregnancy test;

3. Patients with a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions;

4. DSM-IV TR diagnosis of a PDD other than Autistic Disorder, PDD-NOS, Asperger’s Disorder (e.g., Rett’s Disorder, Childhood Disintegrative Disorder), schizophrenia, another psychotic disorder, substance abuse;

5. A significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, or seizure disorder identified by history, physical examination, or laboratory tests.