Clinical trial NCT00191048: Treatment With Atomoxetine Hydrochloride in Children and Adolescents With ADHD
Official title: Open-Label Treatment With Atomoxetine Hydrochloride in Child and Adolescents With Attention-Deficit/Hyperactivity Disorder and Comorbid Dyslexia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention-Deficit/Hyperactivity Disorder
Comorbid Dyslexia
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 105
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of atomoxetine administered once daily in the treatment of children and adolescents with ADHD and comorbid dyslexia.


Eligibility criteria: Inclusion Criteria:

* Patients with ADHD only or ADHD and Dyslexia
* At least 10 years old and no more than 16 years old
* IQ score of 80 or more
* Must be able to swallow capsules

Exclusion Criteria:

* Have received treatment within last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* Weigh less than 25 kg or greater than 70 kg
* Pregnant or breast feeding
* Documented history of bipolar I or II disorder, or psychosis
* Documented history of autism, Asperger's syndrome or pervasive developmental disorder

Primary outcomes:
measure: To assess the effect of atomoxetine,given for approximately 16 weeks, in the treatment of ADHD with Dyslexia as measured by the ADHDRS-IV-Parent:Inv
Secondary outcomes:
measure: To assess the effect of atomoxetine on educational testing, working memory,and adaptive functioning throughout 16 weeks.
Other outcomes:
Locations:
city: Rolling Hills Estate
country: United States
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
state: California
city: Maitland
country: United States
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
state: Florida
city: Miami
country: United States
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
state: Florida
city: Libertyville
country: United States
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
state: Illinois
city: Las Vegas
country: United States
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
state: Nevada
city: Oklahoma City
country: United States
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
state: Oklahoma
city: Nashville
country: United States
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
state: Tennessee
city: Burlington
country: United States
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
state: Vermont
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:
citation: Sumner CR, Gathercole S, Greenbaum M, Rubin R, Williams D, Hollandbeck M, Wietecha L. Atomoxetine for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children with ADHD and dyslexia. Child Adolesc Psychiatry Ment Health. 2009 Dec 15;3:40. doi: 10.1186/1753-2000-3-40.