Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD Adult long term maintenance of response Attention Deficit Hyperactivity Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2017
Healthy volunteers: no

Brief summary:
LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with Attention Deficit/Hyperactivity Disorder (ADHD). Patients will receive, under open label conditions, atomoxetine up to 100 mg/day during the acute, open-label part of the study. Those patients that meet the response criteria will continue the blind phase of the study up to a year. During that period, patients that respond to atomoxetine will be randomized to continue the treatment with atomoxetine or with placebo (neither the patients nor investigators know if patients receive atomoxetine or placebo).

Detailed description:

Arms:
arm 1: Atomoxetine 40-100 milligrams per day (mg/day) orally, once daily or twice daily for 24 weeks, followed by atomoxetine 80-100 mg/day orally, once daily or twice daily for 25 weeks. arm 2: Atomoxetine 40-100 mg/day orally, once daily or twice daily for 24 weeks, followed by placebo orally, once daily for 25 weeks.

Interventions: intervention 1: atomoxetine hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: Oral 40-100 mg/day intervention 2: Oral delivery of matching placebo

Protocol document: