Atomoxetine in children with pervasive developmental disorders.

Completed

Conditions: Atomoxetine treatment.

Registration Number: NL-OMON21784

Lead Sponsor: Accare, division University Center for Child and Adolescent Psychiatry, PO Box 660, 9700 AR Groningen, The Netherlands

Brief Summary: Pieter W. Troost, M.D., Mark-Peter Steenhuis, M.S., Hanneke G. Tuynman-Qua, M.D., Luuk Kalverdijk, M.D., Lawrence Scahill, M.S.N., Ph.D., Jan K. Buitelaar, M.D., Ph.D., Ruud B. Minderaa, M.D. Ph. D., Pieter J. Hoekstra, M.D., Ph. D. Atomoxetine for Attention-Deficit Hyperactivity Disorder Symptoms in Children with Pervasive Developmental Disorders: a Pilot Study. Submitted.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

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;

Exclusion Criteria

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

2. Females with a positive Beta HCG pregnancy test;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the ADHD-Rating Scale-I (ADHDRS).

Secondary Outcome Measures

Name	Time	Method
1. Clinical Global Impression Scale of improvement with regard to ADHD symptoms (CGI-ADHD-I); <br /><br>2. The short form of the Conners’ Parent Rating Scale-Revised (CPRS-R);<br /><br>3. The short form of the Conners’ Teacher Rating Scale-Revised (CTRS-R); <br /><br>4. The Aberrant Behavior Checklist (ABC); <br /><br>5. The Children’s Social Behavior Questionnaire (CSBQ); <br /><br>6. Nisonger Child Behavior Rating Form; <br /><br>7. Children's Yale-Brown Obsessive; <br /><br>8. Compulsive Scale;<br /><br>9. Child Health and Illness Profile-CE;<br /><br>10. Cognitive Battery: WISC-III Mazes, WISC-III Working Memory;<br /><br>11. Vineland Maladaptive Subscale;<br /><br>12. Safety measures: routine lab, physical examination, EKG, open-ended questioning for adverse events.