An Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder
Phase 3
Completed
- Conditions
- Attention Deficit Hyperactivity Disorder
- Registration Number
- NCT00191516
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
A single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by patients, parents and physicians, and its impact on quality of sleep in children (aged 6 through 11 years) with Attention-Deficit/Hyperactivity Disorder treated as outpatients in Germany. An 8-week treatment phase is followed by a 16-week extension period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 257
Inclusion Criteria
- Male or female outpatients who are at least 6 years of age and who will not have reached their 12th birthday
- Diagnosis of ADHD
- Normal intelligence
Exclusion Criteria
- Weigh less than 20 kg or more than 60 kg at study entry
- Other relevant psychiatric diagnoses
- Are at serious suicidal risk as determined by the investigator
- Have a history of severe allergies
- Alcohol or drug abuse within the past 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24
- Secondary Outcome Measures
Name Time Method Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment. O'Brien Sleep Questionnaire during 8 and 24 weeks of treatment
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.
🇩🇪Koln, Germany