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OpenTrials
Completed

NCT Number: NCT00191659

Study of Broader Efficacy of Atomoxetine in the Treatment of ADHD in Children/Adolescents

To test the hypothesis that children/adolescents with ADHD, who are treated with atomoxetine hydrochloride in comparison to standard current therapies have greater improvements in their quality of life.

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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

7 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Basingstoke, Hampshire, RG24 9NL, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of ADHD

Exclusion criteria

  • Patients who weigh less than 20kg at visit 1
  • Have Bipolar Disorder/seizure disorder/taken anticonvulsants for seizures
  • Judged to be at suicidal risk
  • Taking psychotropic medication on a regular basis
  • Hypertension

Treatment and study plan

Atomoxetine Hydrochloride

Drug

Primary outcomes

  1. To test whether atomoxetine given for 10 weeks is superior to standard current therapy as measured by CHIP-CE (Child Health and Illness Profile - Child Edition)

Secondary outcomes

  1. CHIP-CE total mean score after 4 weeks of treatment.

  2. The domains of the CHIP-CE after 4 and 10 weeks of treatment.

  3. The following are measured after both 4 and 10 weeks of treatment:

  4. Family Buden of Illness

  5. Harter Self Perception Profile

  6. ADHD-RS

  7. Clinical Global Impression- Severity

  8. Clinical Global Impression -Improvement

  9. To assess whether changes to the above scales are maintained over long term

  10. Long-term safety of atomoxetine

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomised, Controlled, Open-Label Study of the Broader Efficacy of Atomoxetine Hydrochloride in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents

Important dates

Study start
2004
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Mar 2, 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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