Study of Medication Patch to Treat Children Ages 6-12 With ADHD
Completed · Phase 4 · Has a placebo group
Conditions studied: ADHD, Attention Deficit Hyperactivity Disorder
In brief
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.
Key facts
- Study ID
- NCT00586157
- Run by
- Massachusetts General Hospital
- People needed
- 36
- Starts
- 2006-09-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2012-11-16
Who can join
Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Massachusetts General Hospital — Cambridge, Massachusetts, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.