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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00191659
First Posted: September 19, 2005
Last Update Posted: March 2, 2007
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.
Information provided by:
Eli Lilly and Company
  Purpose
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 Intervention Phase
Attention Deficit Hyperactivity Disorder Drug: Atomoxetine Hydrochloride Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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:
  • CHIP-CE total mean score after 4 weeks of treatment.
  • The domains of the CHIP-CE after 4 and 10 weeks of treatment.
  • The following are measured after both 4 and 10 weeks of treatment:
  • Family Buden of Illness
  • Harter Self Perception Profile
  • ADHD-RS
  • Clinical Global Impression- Severity
  • Clinical Global Impression -Improvement
  • To assess whether changes to the above scales are maintained over long term
  • Long-term safety of atomoxetine

Estimated Enrollment: 200
Study Start Date: June 2004
Estimated Study Completion Date: April 2006
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00191659


Locations
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
Investigators
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
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00191659     History of Changes
Other Study ID Numbers: 6962
B4Z-BP-LYBS
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: March 2, 2007
Last Verified: February 2007

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
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