Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD Children Stimulant Atomoxetine Adolescents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 112
Healthy volunteers: no

Brief summary:
Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who are not tolerating or not responding well to stimulant therapy will be included in this study. Two different strategies for transition from Stimulant to Atomoxetine will be used: Slow (10 weeks) and fast (2 weeks). Changes in ADHD symptoms and tolerability of medication will be compared between the two different switching approaches.

Detailed description:
Study B4Z-EW-LYFJ is a phase IV multicentre, open label, controlled study in approximately 120 patients with ADHD from 6 years to 16 years of age. After the screening period, patients will be randomized (centrally in a 1:1 ratio) either to a transition period of 10 weeks (slow switching arm) or to a transition period of 2 weeks (fast switching arm). After completion of the 10 week open phase patients will be treated for a further 4 weeks with atomoxetine.

Arms:
arm 1: Slow Switching Group (switch from full stimulant dose to atomoxetine, 1.2 mg/kg/day, orally (PO), during 10 weeks then continue treatment up to 1.8 mg/kg/day, PO to 14 weeks arm 2: Fast Switching Group (switch from full stimulant dose to atomoxetine 1.2 mg/kg/day, PO, during 2 weeks then continue treatment up to 1.8 mg/kg/day, PO to 14 weeks

Interventions: intervention 1: Atomoxetine
Intervention descriptions: intervention 1: 1.2 mg/kg/day up to 1.8 mg/kg/day, orally (PO)

Protocol document: