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

Study Overview
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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.

Official Title
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A Randomized, Double-Blind Comparison of the Time Course of Response to Two Extended-Release Oral Delivery Systems for Methylphenidate in Pediatric Patients With Attention Deficit Hyperactivity Disorder in an Analog Classroom Setting: The CoMACS Study

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: Methylphenidate Extended Release Capsules


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Methylphenidate Extended Release Capsules|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| School Day Efficacy |  |  | 
| SKAMP (Swanson Kotkin Agler MFlynn Pelham) ADHD Rating Scale: Deportment Items |  |  | 
| 1.5 - 7.5 hours post-dosing |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SKAMP Attention Items, 1.5-12 hrs; |  |  | 
| PERMP (Permanent Product of arithmetic) (# Problems Attempted & # Complete), 1.5-12 hrs; |  |  | 
| SNAP IV (Swanson Nolan Pelham), day 3 & 7; |  |  | 
| Treatment Emergent Adverse Events, once weekly; |  |  | 
| Barkley Symptom scale, once weekly |  |  | 
| Patient Satisfaction,once weekly |  |  | 
| Parent Satisfaction & Treatment Preference once weekly |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Methylphenidate, Metadate CD, Concerta, COMACS, Attention Deficit Hyperactivity Disorder (ADHD)