Methylphenidate Transdermal System (MTS) in the Treatment of Adult ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Methylphenidate Transdermal System (MTS); placebo patch
Intervention description: 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.; This patch is designed to appear identical to the actual intervention patch
Intervention MeSH terms: Methylphenidate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Attention Deficit Hyperactivity Disorder; ADHD; Adult; Methylphenidate Transdermal System; Daytrana

Summary:

      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.
    

Eligibility criteria:

        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:

          1. Subjects ages 18 to 65, inclusive;

          2. Female subjects are eligible to enter and participate in this study only if:

               1. She is of non-childbearing potential; has a male sexual partner who is surgically
                  sterilized; is on implant of levonorgestrel, injectable progesterone, or an oral
                  contraceptive; has an intrauterine device (IUD); or is sexually inactive with a
                  male partner.

               2. Or agrees to use a double barrier method of contraception (any combination of
                  physical and chemical methods) and has a negative urine pregnancy test at
                  screening interview.

          3. Subject must be in general good health as determined by medical history, ECG, and
             other analysis that, in the judgment of the study physician, would confirm the
             patient's good health.

          4. Subjects must read and write at a level sufficient to provide written informed consent
             and complete study-related materials.

        Exclusion Criteria:

          -  Subjects will not be eligible for inclusion in this study if any of the following
             criteria apply:

               1. Subjects with other current DSM-IV Axis I Disorders including Current or lifetime
                  history of psychosis, current bipolar disorder type I, current Major Depressive
                  Disorder, and Current Anxiety Disorder (unless in the opinion of clinic physician
                  ADHD is the primary disorder and causes the disability seen in the patient);

               2. Subjects with any other DSM-IV Axis II diagnosis so severe that it would suggest
                  non-responsiveness to pharmacotherapy for ADHD or noncompliance with the
                  protocol;

               3. Subjects at risk for suicide or a risk to harm others;

               4. History of Substance Dependence according to DSM-IV criteria within 3 months of
                  screening;

               5. Subjects currently abusing illegal drugs or alcohol are excluded from the study;

               6. Positive urine screen for drugs of abuse at screening for patients who have a
                  significant history of substance use but still meet criteria 4 and 5. Patients
                  not at risk for substance abuse will not be given a urine drug screen;

               7. Subjects in whom stimulants would represent a risk such as those with a history
                  of stimulant abuse,

               8. History of uncontrolled hypertension or significant cardiovascular disease;

               9. Any known or suspected significant medical or psychiatric illnesses (e.g.,
                  hepatic or renal insufficiency, pulmonary (asthma, COPD, etc), gastrointestinal,
                  endocrine, neurological or metabolic disturbances that, in the judgment of the
                  investigator, may impair interpretation of study results or constitute a
                  significant safety concern in the context of the clinical trial;

              10. Medications, including health food supplements judged by the investigator to be
                  likely to have central nervous system activity (for example, St John's Wort,
                  gingko leaf, and melatonin), are not permitted during the study. If the subject
                  is taking the medication prior to study entry, there must be a 7 day washout
                  period prior to Visit 2. We will ask for an honest report of all medications
                  consumed between visits. In the event a medication with psychoactive properties
                  is consumed, the patient will be counseled regarding the use of prohibited
                  medications;

              11. Use of any medication not considered acceptable by the clinical investigator or
                  the medical monitor during the 7-day period before the start of the study (Day
                  1);

              12. Subjects with high BMI (>38) and those with high adipose tissue concentrations in
                  the hip as judged by the clinician.