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

• ClinicalTrials.gov Identifier: NCT00586157
• Recruitment Status: Completed
• First Posted: January 4, 2008
• Results First Posted: January 25, 2011
• Last Update Posted: November 16, 2012
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Timothy Wilens, MD, Massachusetts General Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
ADHD; Attention Deficit Hyperactivity Disorder	Drug: Methylphenidate Transdermal System; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety/Tolerability of Methylphenidate Transdermal System (MTS) for Before-School Dysfunction in Children With Attention Deficit Hyperactivity Disorder (ADHD)
• Study Start Date: September 2006
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: December 2008

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Methylphenidate Transdermal System (MTS)	Drug: Methylphenidate Transdermal System; Medication skin patch titrated to 20mg (at 10 mg and 20 mg doses); Other Name: Daytrana
Placebo Comparator: Placebo	Drug: Placebo; Placebo skin patch titrated to 20mg (at 10 mg and 20 mg doses)

Outcome Measures

Primary Outcome Measures :

1. Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day. [ Time Frame: Baseline and 4 weeks ]
   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).
2. Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM. [ Time Frame: Baseline and 4 weeks ]
   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).

Secondary Outcome Measures :

1. Efficacy Defined as Change From Baseline on Investigator and Parental/Self-report Based Rating Scales and Questionnaires [ Time Frame: Baseline and 4 weeks ]

   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

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts General Hospital

Cambridge, Massachusetts, United States, 02138

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

• Principal Investigator: Timothy Wilens, MD; Massachusetts General Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Timothy Wilens, MD, MD, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00586157
• Other Study ID Numbers: 2006-P-001633
• First Posted: January 4, 2008
• Results First Posted: January 25, 2011
• Last Update Posted: November 16, 2012
• Last Verified: November 2012

Keywords provided by Timothy Wilens, MD, Massachusetts General Hospital:

ADHD; Attention Deficit Hyperactivity Disorder; Daytrana; MTS Patch; Methylphenidate Transdermal System

Additional relevant MeSH terms:

Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Methylphenidate; Central Nervous System Stimulants; Physiological Effects of Drugs; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Neurotransmitter Agents