Clinical trial NCT00485849: A Study of Atomoxetine for Attention Deficit and Hyperactive/Impulsive Behaviour Problems in Children With ASD
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-06-13
Enrollment: 12
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: 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:
measure: To assess whether atomoxetine will be effective in reducing symptoms of inattention and overactivity/impulsivity
measure: To assess whether atomoxetine will be effective for improving social functioning and personal sufficiency in children and adolescents with ASD+ADHD
measure: 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
measure: To assess whether atomoxetine has a positive or negative effect on neuropsychological functioning
measure: To assess the overall influence on functioning and burden on the family
measure: To monitor clinical safety and side effects as assessed by adverse events elicited during open-ended questioning
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: 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
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: