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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00381758

Enrollment

184

Registered

2006-09-28

Start date

2002-05-31

Completion date

2002-08-31

Last updated

2008-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD, Methylphenidate, Metadate CD, Concerta, COMACS, Attention Deficit Hyperactivity Disorder (ADHD)

Brief summary

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.

Interventions

DRUGMethylphenidate Extended Release Capsules

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026