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Completed

NCT Number: NCT00381758

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

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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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Methylphenidate Extended Release Capsules

Drug

Primary outcomes

  1. School Day Efficacy

  2. SKAMP (Swanson Kotkin Agler MFlynn Pelham) ADHD Rating Scale: Deportment Items

  3. 1.5 - 7.5 hours post-dosing

Secondary outcomes

  1. SKAMP Attention Items, 1.5-12 hrs;

  2. PERMP (Permanent Product of arithmetic) (# Problems Attempted & # Complete), 1.5-12 hrs;

  3. SNAP IV (Swanson Nolan Pelham), day 3 & 7;

  4. Treatment Emergent Adverse Events, once weekly;

  5. Barkley Symptom scale, once weekly

  6. Patient Satisfaction,once weekly

  7. Parent Satisfaction & Treatment Preference once weekly

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
Sep 28, 2006
Registry last updated
Mar 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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