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Completed

NCT Number: NCT00485459

Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With ADHD

The purpose of this protocol is to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy in Taiwanese children and adolescents with ADHD.

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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–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject must have ADHD that meet DSM-IV disease diagnostic criteria as well as severity criteria
  • Subjects must be aged 6 to 16 years
  • Subjects must not have taken any medication used to treat ADHD or they must have completed the washout procedures
  • Subjects must be able to swallow capsules
  • Subjects must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit and expected to achieve a score of 80 or more if formal IQ testing were administered.

Exclusion criteria

  • Weigh less than 20 kg or more than 60 kg at study entry
  • Have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder
  • Meet DSM-IV criteria for an anxiety disorder as assessed by the investigator
  • Have a history of any seizure disorder (other than febrile seizures) or prior ECG abnormalities related to epilepsy, or subjects who have taken (or are currently taking) anticonvulsants for seizure control
  • Subjects who have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.

Treatment and study plan

Atomoxetine Hydrochloride

Drug

Placebo

Drug

Primary outcomes

  1. Test the hypothesis that atomoxetine administered as a single-daily dose provides superior efficacy compared with placebo in Taiwanese children and adolescents with ADHD

Secondary outcomes

  1. Compare the improvement in symptoms associated with ADHD in children and adolescents achieved by once-daily dosing of atomoxetine or placebo

  2. Compare the reduction in school-related symptoms between atomoxetine and placebo

  3. Assess the safety and tolerability of once-daily dosing of atomoxetine

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With Attention-Deficit/Hyperactivity Disorder

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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