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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety/Tolerability of Methylphenidate Transdermal System (MTS) for Before-School Dysfunction in Children With Attention Deficit Hyperactivity Disorder (ADHD)

Conditions
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ADHD, Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: Methylphenidate Transdermal System
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methylphenidate Transdermal System (MTS)<br> | Drug: Methylphenidate Transdermal System<br>* Medication skin patch titrated to 20mg (at 10 mg and 20 mg doses)<br>* Other names: Daytrana;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo skin patch titrated to 20mg (at 10 mg and 20 mg doses)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline and 4 weeks | 
| 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). | Baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Attention Deficit Hyperactivity Disorder, Daytrana, MTS Patch, Methylphenidate Transdermal System