OROS Methylphenidate (Concerta) in the Treatment of Adult ADHD

Inclusion Criteria: Adults meeting DSM-IV-Text Revision criteria for ADHD, the Utah Criteria for ADHD, andexperiencing at least moderate impairment (a score of 4 or greater on the CGI-SeverityScale for ADHD at both Screening and Baseline visits) will be enrolled. Other criteriainclude:

1. Subjects ages 18 to 65, inclusive;

2. Female subjects are eligible to enter and participate in this study only if:

• She is of non-childbearing potential; has a male sexual partner who is surgicallysterilized; is on implant of levonorgestrel, injectable progesterone, or an oralcontraceptive; has an intrauterine device (IUD); or is sexually inactive with amale partner.

• Or agrees to use a double barrier method of contraception (any combination ofphysical and chemical methods) and has a negative urine pregnancy test atscreening interview.

3. Subject must be in general good health as determined by medical history, ECG, andother analysis that, in the judgment of the study physician, would confirm thepatient's good health.

4. Subjects must read and write at a level sufficient to provide written informed consentand complete study-related materials.

Exclusion Criteria:

1. Subjects with other current DSM-IV Axis I Disorders including Current or lifetimehistory of psychosis, current bipolar disorder type I, current Major DepressiveDisorder, and Current Anxiety Disorder (unless in the opinion of clinic physician ADHDis 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 suggestnon-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 ofscreening;

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 asignificant history of substance use but still meet criteria 4 and 5. Patients not atrisk 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 ofstimulant abuse,

8. History of uncontrolled hypertension or significant cardiovascular disease;

9. Any known or suspected significant medical or psychiatric illnesses (e.g., hepatic orrenal insufficiency, pulmonary (asthma, chronic obstructive pulmonary disease, etc),gastrointestinal, endocrine, neurological or metabolic disturbances that, in thejudgment of the investigator, may impair interpretation of study results or constitutea significant safety concern in the context of the clinical trial;

10. Medications, including health food supplements judged by the investigator to be likelyto have central nervous system activity (for example, St John's Wort, gingko leaf, andmelatonin), are not permitted during the study. If the subject is taking themedication prior to study entry, there must be a 7 day washout period prior to Visit

11. We will ask for an honest report of all medications consumed between visits. In theevent a medication with psychoactive properties is consumed, the patient will becounseled regarding the use of prohibited medications;

12. Use of any medication not considered acceptable by the clinical investigator or themedical monitor during the 7-day period before the start of the study (Day 1);