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

NCT ID: NCT00586157

Last Updated: 2012-11-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-12-31

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.

Detailed Description

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Conditions

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ADHD Attention Deficit Hyperactivity Disorder

Keywords

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ADHD Attention Deficit Hyperactivity Disorder Daytrana MTS Patch Methylphenidate Transdermal System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Methylphenidate Transdermal System (MTS)

Group Type ACTIVE_COMPARATOR

Methylphenidate Transdermal System

Intervention Type DRUG

Medication skin patch titrated to 20mg (at 10 mg and 20 mg doses)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo skin patch titrated to 20mg (at 10 mg and 20 mg doses)

Interventions

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Methylphenidate Transdermal System

Medication skin patch titrated to 20mg (at 10 mg and 20 mg doses)

Intervention Type DRUG

Placebo

Placebo skin patch titrated to 20mg (at 10 mg and 20 mg doses)

Intervention Type DRUG

Other Intervention Names

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Daytrana

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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Timothy Wilens, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Timothy Wilens, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

References

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Faraone SV, Hammerness PG, Wilens TE. Reliability and Validity of the Before-School Functioning Scale in Children With ADHD. J Atten Disord. 2018 Sep;22(11):1040-1048. doi: 10.1177/1087054714564623. Epub 2015 Jan 9.

Reference Type DERIVED
PMID: 25575616 (View on PubMed)

Wilens TE, Hammerness P, Martelon M, Brodziak K, Utzinger L, Wong P. A controlled trial of the methylphenidate transdermal system on before-school functioning in children with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2010 May;71(5):548-56. doi: 10.4088/JCP.09m05779pur.

Reference Type DERIVED
PMID: 20492851 (View on PubMed)

Other Identifiers

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2006-P-001633

Identifier Type: -

Identifier Source: org_study_id