Efficacy and Safety of Once-Daily Atomoxetine Hydrochloride in Adults With ADHD Over an Extended Period of Time (6 Months)
Phase 4
Completed
- Conditions
- ADHD
- Registration Number
- NCT00190736
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
A study to compare the effect of once-daily atomoxetine versus placebo in treating symptoms of ADHD in adults for up to 6 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 440
Inclusion Criteria
- Male and Female patients with ADHD ages 18-54.
- Patient must have ADHD symptoms that cause problem(s) in the home setting.
Exclusion Criteria
- Have failed to respond to an adequate trial of treatment with an ADHD stimulant medication, bupropion, or other nonstimulant medication.
- Are taking any antipsychotic medication or mood stabilizers within 8 weeks of Visit 1
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Atomoxetine administered orally, QD in the AM, from 25 mg/day to 100 mg/day for 6 months is superior to placebo in ADHD adults.
- Secondary Outcome Measures
Name Time Method Atomoxetine administered QD in the AM, provides superior efficacy in the evenings compared with placebo in ADHD adults.
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.
🇺🇸Middleton, Wisconsin, United States