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A Study in Attention Deficit Hyperactivity Disorder in Children and Adolescents

2014-08-27 03:13:32 | BioPortfolio

Summary

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 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.

Description

The present study is designed to assess the effect of missed doses of daily medication (off-days). On the off-days the patient will take a placebo (sugar pill).Over the four weeks of the actual study there will be six random off-days of study medicine and neither the caregiver, patient nor study doctor will know which days are the missing days.

To cover all aspects of the patients' lives and notably their school time, aside from investigator's assessments, evaluations will also be performed on a daily basis by those involved in their day-to-day life: parents, teachers (on school days) and the patients themselves, using an electronic diary.

Study Design

Allocation: Non-Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Attention Deficit Hyperactivity Disorder

Intervention

Atomoxetine, Osmotic-release oral system methylphenidate, Placebo

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559)
Arnhem
Netherlands
6800 TA

Status

Recruiting

Source

Eli Lilly and Company

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:32-0400

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FOSCO Study (Functional Outcomes Study of OROS (Osmotic-controlled Release Oral Delivery System) Methylphenidate

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Medical and Biotech [MESH] Definitions

A central nervous system stimulant used most commonly in the treatment of attention-deficit disorders in children and for narcolepsy. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE.

A methylphenidate derivative, DOPAMINE UPTAKE INHIBITOR and CENTRAL NERVOUS SYSTEM STIMULANT that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.

A propylamine derivative and selective ADRENERGIC UPTAKE INHIBITOR that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.

The d-form of AMPHETAMINE. It is a central nervous system stimulant and a sympathomimetic. It has also been used in the treatment of narcolepsy and of attention deficit disorders and hyperactivity in children. Dextroamphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulating release of monamines, and inhibiting monoamine oxidase. It is also a drug of abuse and a psychotomimetic.

RED BLOOD CELL sensitivity to change in OSMOTIC PRESSURE. When exposed to a hypotonic concentration of sodium in a solution, red cells take in more water, swell until the capacity of the cell membrane is exceeded, and burst.

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