Attention Deficit Hyperactivity Disorder
Conditions
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.
Interventions
DRUGAtomoxetine
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment. | — |
| O'Brien Sleep Questionnaire during 8 and 24 weeks of treatment | — |
Countries
Germany
Outcome results
None listed