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Completed

NCT Number: NCT00485849

A Study of Atomoxetine for Attention Deficit and Hyperactive/Impulsive Behaviour Problems in Children With ASD

The primary purpose of this study is to evaluate the tolerability and effectiveness of atomoxetine in the treatment of attention problems, hyperactivity, and impulsivity in children with ASD, and secondarily, to evaluate the possible response to atomoxetine on the core symptoms of ASD

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Groningen, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female outpatients between the ages of at least 6 years of age and not more than 17 years of age at visit 1
  • Autistic Spectrum Disorder (DSM-IV TR) diagnosis of Autistic disorder or Asperger syndrome or PDDNOS
  • Clinically significant symptoms of ADHD (i.e. inattention, impulsiveness, and hyperactivity) that have been present for at least six months (for subjects older than 8 years, the onset of symptoms must be before the age of 7 years)
  • Medication-free for at least two weeks for all psychotropic medications (four weeks for fluoxetine or depot-neuroleptics)
  • Patients must also be able to swallow capsules

Exclusion criteria

  • Patients who weigh less than 20 kg or greater than 60 kg at visit 2
  • DSM-IV TR diagnosis of a Pervasive Developmental Disorder other than Autistic Disorder, PDD-NOS, Asperger's Disorder (e.g. Rett's Disorder, Childhood Disintegrative Disorder)
  • Patients who have a history of Bipolar I or II disorder, schizophrenia, psychosis
  • Patients who have a current diagnosis of Major Depression (with or without psychotic features), PTSD
  • Patients with a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control

Treatment and study plan

Atomoxetine Hydrochloride

Drug

Primary outcomes

  1. Test whether atomoxetine is effective in reducing symptoms of inattention and overactivity/impulsivity as measured by the AHDHRS-IV-Parent:Inv scale in pediatric outpatients with ASD accompanied by ADHD behavior problems

Secondary outcomes

  1. To assess whether atomoxetine will be effective in reducing symptoms of inattention and overactivity/impulsivity

  2. To assess whether atomoxetine will be effective for improving social functioning and personal sufficiency in children and adolescents with ASD+ADHD

  3. To assess whether atomoxetine has a positive or negative effect on frequently associated symptoms as impulsive aggression, agitation, self-injurious behavior, troublesome repetitive behavior and poor motor coordination

  4. To assess whether atomoxetine has a positive or negative effect on neuropsychological functioning

  5. To assess the overall influence on functioning and burden on the family

  6. To monitor clinical safety and side effects as assessed by adverse events elicited during open-ended questioning

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

An Open Label Pilot Study of Atomoxetine for Attention Deficit and Hyperactive/Impulsive Behavior Problems in Children and Adolescents With Autistic Spectrum Disorders

Important dates

Study start
2004
Study completion
2004
First posted
Jun 13, 2007
Registry last updated
Jun 13, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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