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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191659
First received: September 12, 2005
Last updated: February 28, 2007
Last verified: February 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   7 Years to 15 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00191659     History of Changes
Other Study ID Numbers: 6962, B4Z-BP-LYBS
Study First Received: September 12, 2005
Last Updated: February 28, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Atomoxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014