Please select the eligibility criteria that correspond to the clinical trial below.
Title: Pharmacogenetic Studies on Attention Deficit Hyperactivity Disorder
Brief Summary: The ultimate goal of this study is to find the association between specific polymorphism of candidate genes and medication response in attention deficit hyperactivity disorder (ADHD) patients. These results will lead the investigators' team: (1) to resolve controversies over inconsistent findings in previous pharmacogenetic studies; (2) to study the medication effect on the neuropsychological functions that are useful candidate endophenotypes for ADHD; (3) to delineate the nature and the effect of gene-gene interaction in the drug response of ADHD patients.


Options:
A: Inclusion Criteria:

* Must sign informed consent.
* Male or female 6-12 years old.
* Negative pregnancy test.
* Meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition - Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD.
* No co-morbid illness that could affect safety, tolerability or interfere with participation.
* Blood pressure (BP) within the 95th percentile for age, gender, and height.
* Willing and able to comply with all the requirements defined in protocol.

Exclusion Criteria:

* Current controlled (requiring a restricted medication) or uncontrolled co-morbid psychiatric diagnosis (except Oppositional Defiant Disorder \[ODD\]).
* At risk for suicidal or violent behavior towards self or others.
* History of a suicide attempt.
* History of a structural cardiac abnormality or other serious cardiac problems.
* Non-responder to psychostimulant treatment.
* Is overweight.
* Seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
* Has Conduct Disorder.
* Known history of alcohol or other substance abuse within the last 6 months.
* Any abnormal thyroid function.
* A concurrent chronic or acute illness, disability, or other condition that might confound results of safety assessments.
* Has had treatment with any known liver altering agents within 30 days prior to Screening.
* Taking any excluded medication.
* Previous use of DAYTRANA.
* Taking other medications that have Central Nervous System (CNS) effects.
* Female subject is pregnant or lactating.
* Has any skin disease, or history of any chronic skin disease, skin cancer, skin manifestations of allergic disease, or other dermatologic conditions.
* Has sensitive-skin syndrome or has sensitivities to the ingredients in soaps, lotions, cosmetics or adhesives.
* Has clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites.
* A documented allergy, hypersensitivity or intolerance of methylphenidate (MPH) or any components found in DAYTRANA.
B: Inclusion Criteria:

Patients are eligible to be included in this study only if they meet all of the following criteria:

1. Patients will be outpatients who are between 7 and 18 years of age.
2. Patients must have ADHD that meet the Diagnostic and Statistical Manual of Mental disorders, 4th edition (DSM-IV) disease diagnostic criteria assessed by the investigator's clinical evaluation, as well as confirmed by the Chinese version of the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Epidemiological Version (K-SADS-E).
3. Patients must have a Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) score \> 4 at Visit 1.
4. Patients must be psychotropic medication-naïve. Patients will be considered to be medication-naïve if they have never received medications specifically to treat ADHD.
5. Patients must have laboratory results, including serum chemistries, hematology, and urine analysis showing no significant abnormalities and no clinical information that should preclude a patient's participation at study entry. A patient with a significant abnormal laboratory result mat enter the study if, after appropriate medical evaluation, the result dose not indicate a serious medical condition that in the investigator's judgment would preclude participation.
6. Patients and parents (or legal representative) must have a degree of understanding sufficient to be able to communicate suitably with the investigator.
7. Patients must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as achieving a score of 80 or more when IQ testing is administrated.
8. Patients must have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including neuropsychological testing and venipunctures.

Exclusion Criteria:

Patients will be excluded from the study if they meet any of the following criteria:

1. Patients with current or past history of schizophrenia, schizoaffective Disorder, organic psychosis, bipolar I or II disorder, autism, Asperger's disorder, or pervasive developmental disorder. Other comorbid psychiatric disorders are not excluded if the ADHD symptoms are the primary source of impairment for the patient.
2. Patients with a history of any seizure disorder (other than febrile convulsion) or patients who are taking anticonvulsants for seizure control.
3. Patients have been at serious suicidal risk, determined by the investigator.
4. Patients with a history of severe allergies to more than one class of medications or multiple adverse drug reactions.
5. Patients with a history of alcohol or drug abuse within the past 3 months, or who are currently using alcohol, drugs of abuse, or any described or over-the-counter medication in a manner that the investigator considers indicative of abuse.
6. Patients with cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure.
7. Patients who are likely to need psychotropic medications apart from methylphenidate or atomoxetine, including Chinese medicine or health-food supplements that have central nervous system activity.
C: Inclusion Criteria:

* Patients who have successfully completed one of the following earlier ALZA studies: CR005992, C-97-033 (and then successfully completed C-98-011), CR005989, or CR005995, without significant drug-related adverse events
* whose primary care physician agrees that it is appropriate to participate in this study
* who agree to take only the OROS® (methylphenidate HCl) supplied and no other methylphenidate dosage form or other medications for the treatment of ADHD during the study
* who are able to comply with the study visit schedule and whose parent(s) and teachers are willing and able to complete the protocol-specified assessments
* who have normal urinalysis, hematological and blood chemistry values or, if values are outside the normal range, they are determined not clinically significant by the investigator

Exclusion Criteria:

* Patients having clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract
* having any coexisting medical condition or are taking any medication that is likely to interfere with safe administration of methylphenidate
* having a known hypersensitivity to methylphenidate
* having a history of high blood pressure or who have a blood pressure (systolic or diastolic) equal to or greater than the 95th percentile for age, gender and height
* if female, have begun menstruation
D: Inclusion Criteria:

* DSM-IV diagnosis of ADHD, any subtype
* DSM-IV diagnosis of a disruptive behavior disorder, including CD or ODD
* Evidence of serious physical aggression, as rated on the Overt Aggression Scale-Modified, and as determined by parent or guardian ratings on the NCBRF D-Total Score. In addition, the blinded clinician must assign a clinical global impressions severity score of 4 or greater for aggression.
* Prior to random assignment, participants must be free of all psychotropic medicines for 2 weeks for most drugs (such as most antidepressants, alpha agonists, beta blockers, anxiolytics, mood stabilizers, and antihistamines), and 4 weeks for depot antipsychotics and fluoxetine.

Exclusion Criteria:

* Full-scale IQ below 71
* Pregnancy or a history of seizure disorder or other neurological or medical disorders for which medication may present a considerable risk
* Abnormal liver function
* Pervasive developmental disorder, schizophrenia or other psychotic disorders, or eating disorders
* Currently taking other psychotropic medications from which discontinuation would present a significant risk. Participants may not discontinue a satisfactory medication to participate.
* Presence or history of major depressive disorder
* Diagnosis of bipolar disorder
* A hypomanic/biphasic score of 36 or greater as rated by child's parent on the General Behavior Inventory and confirmed by clinician as indication of mood disorder
* Active substance abuse disorder or lack of control of substance use that does not allow for safe medication administration
* Evidence of current child abuse or neglect
* History of suicide attempt in the past year or current suicidal ideation with plan and/or intent
* Family history of type II diabetes in two or more first degree relatives, defined as biological parents and/or full biological siblings

Answer: B