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

Mass General Brigham

Status and phase

Completed

Phase 4

Conditions

Attention Deficit Hyperactivity Disorder

ADHD

Treatments

Drug: Placebo

Drug: Methylphenidate Transdermal System

Study type

Interventional

Funder types

Other

Identifiers

NCT00586157

2006-P-001633

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

6 to 12 years old

Volunteers

No 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.