Study of Medication Patch to Treat Children Ages 6-12 With ADHD
This study has been completed.
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Timothy Wilens, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00586157
First received: December 21, 2007
Last updated: November 9, 2012
Last verified: November 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
ADHD Attention Deficit Hyperactivity Disorder |
Drug: Methylphenidate Transdermal System Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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) |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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).
- 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 ] [ Designated as safety issue: No ]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:
- Efficacy Defined as Change From Baseline on Investigator and Parental/Self-report Based Rating Scales and Questionnaires [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
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
| Enrollment: | 36 |
| Study Start Date: | September 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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)
Other Name: Placebo
|
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586157
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
No publications provided by Massachusetts General Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Timothy Wilens, MD, MD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00586157 History of Changes |
| Other Study ID Numbers: | 2006-P-001633 |
| Study First Received: | December 21, 2007 |
| Results First Received: | November 22, 2010 |
| Last Updated: | November 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Massachusetts General Hospital:
|
ADHD Attention Deficit Hyperactivity Disorder Daytrana MTS Patch Methylphenidate Transdermal System |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Methylphenidate |
Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013