Assessing the Effect of Missing Doses (Off-Days) of Daily Medication in Patients Stable on Pharmacotherapy for ADHD Receiving Atomoxetine or OROS Methylphenidate: A Parallel Matched Group Clinical Study (On/Off Study) (EMD)

NCT01127646 Phase 4 TERMINATED Results posted

The main purpose of the study is to help to understand the effect on children and adolescents who are stable on treatment with atomoxetine or osmotic-release oral system (OROS) methylphenidate for attention-deficit/hyperactivity disorder (ADHD) of not taking the medication for a maximum of 6 days over a 28-day study treatment period.

Details

Lead sponsor	Eli Lilly and Company
Phase	Phase 4
Status	TERMINATED
Enrolment	23
Start date	2010-06
Completion	2011-05

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

• Atomoxetine
• Osmotic-release oral system methylphenidate
• Placebo

Primary outcomes

• Daily Parent Report of Evening and Morning Behavior-Revised (DPREMB-R) Scale Mean Total Score (On-Days Versus Off-Days) During the 4-Week Treatment Period — Baseline through 4 weeks
  Parent-completed 11-item questionnaire; measures difficulty level of and 8 common evening behaviors (such as, sit through dinner) and 3 common morning behaviors (such as, get out of bed). Each item is scored on a 4-point Likert scale ranging from 0 (no difficulty) to 3 (a lot of difficulty). Total score (evening+morning) range is 0 to 33. Higher scores indicate greater difficulty in evening and morning behavior. DPREMB-R total score between days without missing doses (on-days) and days with missing doses (off-days) was not analyzed due to the insufficient sample size.

Countries

Netherlands, Spain, Sweden