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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586157
• Other study ID #: 2006-P-001633
• Status: Completed
• Phase: Phase 4
• First received: December 21, 2007
• Last updated: November 9, 2012
• Start date: September 2006
• Est. completion date: December 2008

Study information

• Verified date: November 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Methylphenidate Transdermal System
Medication skin patch titrated to 20mg (at 10 mg and 20 mg doses)
• Placebo
Placebo skin patch titrated to 20mg (at 10 mg and 20 mg doses)

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No