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

Primary Purpose

ADHD, Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Methylphenidate Transdermal System
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring ADHD, Attention Deficit Hyperactivity Disorder, Daytrana, MTS Patch, Methylphenidate Transdermal System

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Methylphenidate Transdermal System (MTS)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
December 21, 2007
Last Updated
November 9, 2012
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00586157
Brief Title
Study of Medication Patch to Treat Children Ages 6-12 With ADHD
Official Title
Efficacy and Safety/Tolerability of Methylphenidate Transdermal System (MTS) for Before-School Dysfunction in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Attention Deficit Hyperactivity Disorder
Keywords
ADHD, Attention Deficit Hyperactivity Disorder, Daytrana, MTS Patch, Methylphenidate Transdermal System

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylphenidate Transdermal System (MTS)
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Methylphenidate Transdermal System
Other Intervention Name(s)
Daytrana
Intervention Description
Medication skin patch titrated to 20mg (at 10 mg and 20 mg doses)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo skin patch titrated to 20mg (at 10 mg and 20 mg doses)
Primary Outcome Measure Information:
Title
Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day.
Description
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).
Time Frame
Baseline and 4 weeks
Title
Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM.
Description
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).
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Efficacy Defined as Change From Baseline on Investigator and Parental/Self-report Based Rating Scales and Questionnaires
Description
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
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Wilens, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25575616
Citation
Faraone SV, Hammerness PG, Wilens TE. Reliability and Validity of the Before-School Functioning Scale in Children With ADHD. J Atten Disord. 2018 Sep;22(11):1040-1048. doi: 10.1177/1087054714564623. Epub 2015 Jan 9.
Results Reference
derived
PubMed Identifier
20492851
Citation
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. doi: 10.4088/JCP.09m05779pur.
Results Reference
derived

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

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