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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Timothy Wilens, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00586157
First received: December 21, 2007
Last updated: November 9, 2012
Last verified: November 2012
History of Changes

December 21, 2007
November 9, 2012
September 2006
December 2008   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    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).
  • 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 ] [ Designated as safety issue: No ]
    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).
Efficacy defined as change from baseline on the investigator rated DSM-IV based ADHD Rating Scale, both over the course of the day and specifically in the AM hours. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00586157 on ClinicalTrials.gov Archive Site
Efficacy Defined as Change From Baseline on Investigator and Parental/Self-report Based Rating Scales and Questionnaires [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]

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
Efficacy defined as change from baseline on investigator and parental/self-report based rating scales and questionnaires [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Medication Patch to Treat Children Ages 6-12 With ADHD
Efficacy and Safety/Tolerability of Methylphenidate Transdermal System (MTS) for Before-School Dysfunction in Children With Attention Deficit Hyperactivity Disorder (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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • ADHD
  • Attention Deficit Hyperactivity Disorder
  • Drug: Methylphenidate Transdermal System
    Medication skin patch titrated to 20mg (at 10 mg and 20 mg doses)
    Other Name: Daytrana
  • Drug: Placebo
    Placebo skin patch titrated to 20mg (at 10 mg and 20 mg doses)
    Other Name: Placebo
  • Active Comparator: Methylphenidate Transdermal System (MTS)
    Intervention: Drug: Methylphenidate Transdermal System
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Wilens TE, Hammerness P, Martelon M, Brodziak K, Utzinger L, Wong P. A controlled trial of the methylphenidate transdermal system on before-school functioning in children with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2010 May;71(5):548-56.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00586157
2006-P-001633
No
Timothy Wilens, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Timothy Wilens, MD Massachusetts General Hospital
Massachusetts General Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP