Phase 4 Completed N=30 Randomized Triple-blind Treatment

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

Attention Deficit Hyperactivity Disorder

Source: ClinicalTrials.gov NCT00586157 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2011

Primary outcomePrimary: Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day. — 14.76; 28.33 Units on a scale — p=<.001

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day.	14.76; 28.33	<.001 sig
PRIMARY Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM.	10.03; 23.22	.003 sig
SECONDARY Efficacy Defined as Change From Baseline on Investigator and Parental/Self-report Based Rating Scales and Questionnaires	12.76; 31.37	.001 sig

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00586157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.