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OpenTrials
Completed

NCT Number: NCT00191048

Treatment With Atomoxetine Hydrochloride in Children and Adolescents With ADHD

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.

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Key information

Conditions

Attention-Deficit/Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Comorbid Dyslexia Mental Disorders Neurodevelopmental Disorders

Age range

10 year–16 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, Rolling Hills Estate, California, United States

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Atomoxetine

Drug

Primary outcomes

  1. 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

  1. To assess the effect of atomoxetine on educational testing, working memory,and adaptive functioning throughout 16 weeks.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Open-Label Treatment With Atomoxetine Hydrochloride in Child and Adolescents With Attention-Deficit/Hyperactivity Disorder and Comorbid Dyslexia

Important dates

Study start
2003
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Jan 26, 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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