Study of Broader Efficacy of Atomoxetine in the Treatment of ADHD in Children/Adolescents
Phase 3
Completed
- Conditions
- Attention Deficit Hyperactivity Disorder
- Registration Number
- NCT00191659
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
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