Study of Medication Patch to Treat Children Ages 6-12 With ADHD
Information source: Massachusetts General Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: ADHD; Attention Deficit Hyperactivity Disorder
Intervention: Methylphenidate Transdermal System (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s):
Timothy Wilens, MD, Principal Investigator, Affiliation: Massachusetts General Hospital
Overall contact:
Linsey Utzinger, BA, Phone: 617-503-1043, Email: lutzinger@partners.org
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.
Clinical Details
Official title: Efficacy and Safety/Tolerability of Methylphenidate Transdermal System (MTS) for Before-School Dysfunction in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: Efficacy defined as change from baseline on investigator and parental/self-report based rating scales and questionnaires
Eligibility
Minimum age: 6 Years.
Maximum age: 12 Years.
Gender(s): Both.
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.
Locations and Contacts
Linsey Utzinger, BA, Phone: 617-503-1043, Email: lutzinger@partners.org
Massachusetts General Hospital, Cambridge, Massachusetts 02138, United States; Recruiting
Linsey Utzinger, BA, Phone: 617-503-1043, Email: lutzinger@partners.org
Timothy Wilens, MD, Principal Investigator
Additional Information
Starting date: September 2006
Ending date: December 2008
Last updated: December 21, 2007
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