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The COMACS Study: A Compariso...

The COMACS Study: A Comparison of Methylphenidates in an Analog Classroom Setting

Last Updated: 2008-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2002-08-31

Brief Summary

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This study was designed to compare Concerta Extended Release tablets with Metadate CD capsules in children with ADHD who were between 6 and 12 years old. The effects on ADHD symptoms, and any side effects of treatment, were measured for 12 hours after dosing in a simulated classroom. The treatments were blinded and the effects were compared with a Placebo.

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Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Methylphenidate Extended Release Capsules

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 6 -12 years of age, inclusive
* Have a diagnosis of ADHD
* Receiving an approved form of MPH (methylphenidate) and have demonstrated clinical improvement during this treatment.

Exclusion Criteria

* IQ below 80.
* The patient, or a first-degree relative, has a confirmed diagnosis of Tourette's syndrome or a clinically significant tic disorder.
* History of seizures (excluding uncomplicated childhood febrile seizures).
* Myocardial infarction within 3 months of study entry, or has a history of cardiac disease, congenital cardiac abnormality, glaucoma, hyperthyroidism.
* Comorbid psychiatric diagnosis.
* Exhibits extreme aggressive behavior or destruction of property, marked anxiety, tension, or agitation.

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers