Skip to main content
OpenTrials
Completed

NCT Number: NCT00586157

Study of Medication Patch to Treat Children Ages 6-12 With ADHD

The purpose of this study is to investigate the effectiveness of a medication skin patch called Methylphenidate Transdermal System (MTS). We will compare the MTS medicated patch to a placebo patch. We want to find out how well it treats ADHD during the early morning hours before a child leaves for school or summertime routines.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit Hyperactivity Disorder 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

Primary location

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female outpatients 6 to 12 years of age.
  • Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview.
  • Participation in structured morning routine (e.g. school, camp, or other organized activities).

Exclusion criteria

  • Mental retardation (IQ <75).
  • Subjects with a medical condition, or treatment that will either jeopardize subject safety or affect the scientific merit of the study.
  • Subjects with moderate to severe dermatological atopy.
  • Subjects with known structural cardiac abnormalities.
  • Organic brain disorders.
  • Seizure Disorder.
  • Subjects with Tourette's syndrome, or a history of psychosis or bipolar disorder.
  • Subjects with current comorbid psychopathology that in the investigator's opinion will warrant immediate treatment or will interfere with the safe execution of the protocol (i.e. Anxiety or Major Depressive Disorder rated as moderate on CGI).
  • Subjects with a history of intolerable adverse effects or non-response to methylphenidate.
  • Pregnant or nursing females.

Treatment and study plan

Methylphenidate Transdermal System

Drug

Medication skin patch titrated to 20mg (at 10 mg and 20 mg doses)

Other names: Daytrana

Placebo

Drug

Placebo skin patch titrated to 20mg (at 10 mg and 20 mg doses)

Primary outcomes

  1. Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day.

    Time frame: Baseline and 4 weeks

    Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe).

  2. Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM.

    Time frame: Baseline and 4 weeks

    Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe).

Secondary outcomes

  1. Efficacy Defined as Change From Baseline on Investigator and Parental/Self-report Based Rating Scales and Questionnaires

    Time frame: Baseline and 4 weeks

    The questionnaire includes two a sections, a clinician rated 20-item scale and a 14-item self-report section completed collaboratively by child and parent/guardian.

    Units on the clinician rated scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. Units on the self-report section ranged from 0-2 on a scale of severity, with 0 being the least severe item score and 2 being the most severe. The possible range of scores for the questionnaire is 88

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Efficacy and Safety/Tolerability of Methylphenidate Transdermal System (MTS) for Before-School Dysfunction in Children With Attention Deficit Hyperactivity Disorder (ADHD)

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 4, 2008
Registry last updated
Nov 16, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.