Maintenance of Benefit With Atomoxetine Hydrochloride in Adolescents With ADHD
Phase 4
Completed
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Registration Number
- NCT00191035
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of this study is to assess the efficacy, safety and tolerability of atomoxetine administered once daily in the treatment of adolescents with ADHD after 8 weeks and after 52 weeks
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 520
Inclusion Criteria
- Patients must have ADHD.
- Must be 13-16 years of age.
- Must be able to swallow capsules.
- Expected to achieve score of 70 or more on IQ test
- Willing and reliable to keep appts. for clinic visits and test
Exclusion Criteria
- Treatment within last 30 days with a drug that has not received regulatory approval for any indication.
- Patients who weigh less than 40 kg or greater than 70 kg.
- Patients with documented history of Bipolar I or II disorder, or psychosis
- Patients with documented history of autism, asperger's syndrome or pervasive developmental disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Assess the difference in maintenance of response at 52 weeks between atomoxetine dosed at 0.8mg/kg/day vs.1.4 mg/kg/day measured by ADHDRS-IV-Parent:Inv
- Secondary Outcome Measures
Name Time Method Assess the relationship between different dosing titrations & tolerability at 4 wks, & efficacy at 8 wks; effect of atomoxetine on adaptive,family functioning, academic performance, GPA, health status,health risk behaviors at 8 wks & 52 wks
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
🇺🇸Nashville, Tennessee, United States