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

NCT00586157 | Completed Phase 4 Results

• 1 other identifier: 2006-P-001633
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD; Attention Deficit Hyperactivity Disorder

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Efficacy Defined as Change From Baseline on Investigator and Parental/Self-report Based Rating Scales and Questionnaires

  Baseline and 4 weeks

Study Arms (2)

Methylphenidate Transdermal System (MTS)

ACTIVE COMPARATOR

Drug: Methylphenidate Transdermal System

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Methylphenidate Transdermal System DRUG

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

Also known as: Daytrana

Methylphenidate Transdermal System (MTS)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (2)

• 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.

  PMID: 25575616 DERIVED

• 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.

  PMID: 20492851 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Timothy Wilens, MD
• Organization: Massachusetts General Hospital

twilens@partners.org

617-726-1731

Study Officials

• Timothy Wilens, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 4, 2008
• Study Start: September 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 16, 2012
• Results First Posted: January 25, 2011

Record last verified: 2012-11

Locations

US (1)