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Sponsors and Collaborators: |
University of Utah Shire Pharmaceutical Development |
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Information provided by: | University of Utah |
ClinicalTrials.gov Identifier: | NCT00506285 |
This study will look at the effectiveness of Methylphenidate Transdermal System (MTS) in treating adult ADHD. MTS has received FDA approval for childhood ADHD but this is the first trial for adult ADHD. Subjects will experience two screening visits and one baseline visit. Those who meet admission criteria will enter the double-blind phase. This will involve two 4-week treatment periods one of which will involve the use of MTS and the other a placebo patch. Subjects who complete the double-blind phase will be allowed to enter a 180-day, open-label MTS phase designed to assess long-term effects.
Condition | Intervention | Phase |
---|---|---|
Attention Deficit Hyperactivity Disorder |
Drug: Methylphenidate Transdermal System (MTS) Other: placebo patch |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Methylphenidate Transdermal System (MTS) in the Treatment of Adult ADHD |
Estimated Enrollment: | 60 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Methylphenidate Transdermal System
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Drug: Methylphenidate Transdermal System (MTS)
MTS is an advanced patch product that provides methylphenidate evenly mixed with the adhesive. This formulation allows good adhesion and a wide range of dose sizes. MTS patch sizes of 12.5, 18.75, 25 and 37.5cm2 are equivalent to nominal doses over a 9-hour wear time of 10, 15, 20 and 30mg of MPH.
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B: Placebo Comparator
Placebo patch
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Other: placebo patch
This patch is designed to appear identical to the actual intervention patch
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ADHD affects from 3 to 5% of children, persists into adolescence in 40 to 70% of these children and continues into adulthood in at least 50% of affected adolescents. Methylphenidate was the first medication shown to be effective in treatment for adults with ADHD and continues to be widely used. While the extended release formulations represent an improvement over the immediate release versions, significant problems remain for many patients. In particular, most have been designed with the goal of providing medication only during school hours and a short time period after school. In adults, there is a frequent need for much more extended duration of treatment. MTS is a new form of methylphenidate that provides medication in a transdermal patch delivery system. It has a very even, slowly ascending pharmacokinetic profile. MTS's very stable slowly increasing blood level should overcome the problems noted above with a delivery system that is more convenient for many patients. It is currently approved for treatment of childhood ADHD, with effectiveness and safety profiles similar to other forms of methylphenidate. This study will be the first to evaluate the effectiveness and safety of MTS in adult ADHD.
This is a double-blind, placebo-controlled, randomized, crossover trial comparing MTS with placebo patch. The double-blind trial will be preceded by an enrollment period consisting of two screening visits followed as quickly as possible by a baseline visit. Patients who continue to meet admission criteria at baseline will be randomized into the first of two 4-week treatment periods. We will attempt to reach the highest tolerated dose size of MTS within 2 weeks and then observe the response over the last two weeks of each crossover phase. The double-blind period will be followed by a 180 day open-treatment, flexible-dose phase designed to assess long-term effects.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adults meeting DSM-IV-Text Revision criteria for ADHD, the Utah Criteria for ADHD, and experiencing at least moderate impairment (a score of 4 or greater on the CGI-Severity Scale for ADHD at both Screening and Baseline visits) will be enrolled. Other criteria include:
Female subjects are eligible to enter and participate in this study only if:
Exclusion Criteria:
Subjects will not be eligible for inclusion in this study if any of the following criteria apply:
Contact: Corinne Halls, MS | 801-581-8806 | Corinne.Halls@hsc.utah.edu |
Contact: Erika Williams, MSW | 801-581-8806 | Erika.Williams@hsc.utah.edu |
United States, Utah | |
University of Utah School of Medicine, Department of Psychiatry, Mood Disorders Clinic | Recruiting |
Salt Lake City, Utah, United States, 84132 | |
Contact: Frederick W. Reimherr, MD 801-581-8806 fred.reimherr@hsc.utah.edu | |
Principal Investigator: Frederick W. Reimherr, MD |
Principal Investigator: | Frederick W. Reimherr, MD | University of Utah |
Responsible Party: | University of Utah ( Frederick Reimherr, M.D. ) |
Study ID Numbers: | SPD485.420-Reimherr |
Study First Received: | July 23, 2007 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00506285 |
Health Authority: | United States: Institutional Review Board |
Attention Deficit Hyperactivity Disorder ADHD Adult Methylphenidate Transdermal System Daytrana |
Signs and Symptoms Dopamine Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood |
Methylphenidate Neurologic Manifestations Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Dyskinesias |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Nervous System Diseases Central Nervous System Stimulants Dopamine Agents Central Nervous System Agents Pharmacologic Actions |