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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485849
• Other study ID #: 6639
• Secondary ID: B4Z-UT-S003
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2007
• Last updated: June 11, 2007
• Start date: February 2004
• Est. completion date: October 2004

Study information

• Verified date: June 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Impulsive Behavior

Intervention

Drug:
• Atomoxetine Hydrochloride

Locations

Country	Name	City	State
Netherlands	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess whether atomoxetine will be effective in reducing symptoms of inattention and overactivity/impulsivity
Secondary	To assess whether atomoxetine will be effective for improving social functioning and personal sufficiency in children and adolescents with ASD+ADHD
Secondary	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
Secondary	To assess whether atomoxetine has a positive or negative effect on neuropsychological functioning
Secondary	To assess the overall influence on functioning and burden on the family
Secondary	To monitor clinical safety and side effects as assessed by adverse events elicited during open-ended questioning

External Links

•   Lilly Clinical Trial Registry