NCT00191659
Completed
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Attention Deficit Hyperactivity Disorder
- Sponsor
- Eli Lilly and Company
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- 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)
- Status
- Completed
- Last Updated
- 19 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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
- 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
Study Sites (1)
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