Atomoxetine for Attention-deficit hyperActivity disorder Symptoms in children with pervasive developmental disorders: a pilot study

Accare (The Netherlands)0 sites12 target enrollmentFebruary 26, 2007

Overview

Phase: 未知
Intervention: Not specified
Conditions: Attention Deficit Hyperactivity Disorder (ADHD), Pervasive Developmental Disorders
Sponsor: Accare (The Netherlands)
Enrollment: 12
Status: Completed
Last Updated: 5 years ago

Registry

who.int

Start Date

February 26, 2007

End Date

October 20, 2004

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

Accare (The Netherlands)

•1\. Males and females between the ages of at least six years of age and not more than 17 years of age at visit one
•2\. ASD (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition \[DSM\-IV TR] diagnosis of autistic disorder or Asperger?s disorder or Pervasive Developmental Disorder (PDD) not otherwise specified, established by clinical assessment and corroborated by Autism Diagnostic Interview scores
•3\. Patients must score greater than four on the Clinical Global Impressions (CGI)\-severity scale 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 Attention\-Deficit/Hyperactivity Rating Scale four (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\. Intelligence Quotient (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\-Human Chorionic Gonadotropin (HCG) pregnancy test
•3\. Patients with a history of severe allergies to more than one class of medications or multiple adverse drug reactions
•4\. DSM\-IV TR diagnosis of a PDD other than Autistic Disorder, PDD\- Not Otherwise Specified, 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