Methylphenidate Transdermal System (MTS) in the Treatment of Adult ADHD
|Attention Deficit Hyperactivity Disorder||Drug: Methylphenidate Transdermal System (MTS) Other: placebo patch||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Methylphenidate Transdermal System (MTS) in the Treatment of Adult ADHD|
- Wender Reimherr Adult Attention Deficit Disorder Scale [ Time Frame: Double-blind endpoints during MTS and placebo arms ]This scale measures the 7 domains of the Utah Criteria for Adult ADHD. Total scores run from 0 to 28. Normative samples average below 5. The worst possible score is 28.
- Conners' Adult ADHD Rating Scales (CAARS) [ Time Frame: Double-blind endpoints for MTS and placebo arms ]Measures the DSM based ADHD criteria of Inattention and Hyperactivity/Impulsivity. There are 30 items scored 0-3 for a minimum score of 0 (no symptoms) and a maximum score of 90 worst possible symptoms.
|Study Start Date:||June 2007|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
This arm was 4 weeks long. Subjects were treated using Methylphenidate Transdermal System. Patients were seen weekly, phone contact was made between visits and dosing could be adjusted as a result of the phone contact. MTS was initiated using a 12.5 cm patch. The dose was increased during the first 2 weeks based on treatment response and side effects to the largest tolerated dose/patch size. It was held steady the last 2 weeks.
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.
Other Name: Daytrana
Placebo Comparator: B
This arm was 4 weeks long. Placebo patch was initiated using a 12.5 cm patch and then increased to the largest tolerated patch size during the first 2 weeks and held steady the last two weeks. Subjects were seen weekly, phone contact was made between visits and dosing could be adjusted as a result of the phone visit.
Other: placebo patch
This patch is designed to appear identical to the actual intervention patch
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00506285
|United States, Utah|
|University of Utah School of Medicine, Department of Psychiatry, Mood Disorders Clinic|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Frederick W. Reimherr, MD||University of Utah|