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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00191659
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : March 2, 2007
Information provided by:
Eli Lilly and Company

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: Atomoxetine Hydrochloride Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : June 2004
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   7 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00191659

United Kingdom
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, United Kingdom, RG24 9NL
Sponsors and Collaborators
Eli Lilly and Company
Study Director: 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) Eli Lilly and Company

Additional Information: Identifier: NCT00191659     History of Changes
Other Study ID Numbers: 6962
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: March 2, 2007
Last Verified: February 2007

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs