Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Multi-center, Double-blind, Placebo-controlled, Cross-over Study Evaluating the Safety and Efficacy of Dex-Methylphenidate Extended Release 30 mg vs. 20 mg as Measured by SKAMP-Combined Scores in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting.
Brief Summary: This study will evaluate the efficacy and safety of Dex-Methylphenidate Extended Release 30 mg compared to 20 mg in pediatric patients ages 6-12 with Attention-Deficit Hyperactivity Disorder (ADHD) in a 12-hour laboratory classroom setting.


Options:
A: Main inclusion criteria:

1. Female or male subjects with age between 6 and 18 years old.
2. Subjects with documented diagnosis of one of the three presentations of Attention Deficit Hyperactivity Disorder (ADHD) within one year by investigator assessment using Diagnostic \& Statistical Manual for Mental Disorders-Fifth Edition (DSM-5).
3. Both subjects and parents/guardians have provided their signed and dated informed consent form for the study.

Main exclusion criteria:

1. Subjects have received ADHD treatment for over 1 year or those who have received other ADHD treatment within 30 days prior to the study treatment initiation.
2. By investigator's evaluation, subjects are very anxious, tense or agitated.
3. Subjects known to be allergic to any ORADUR®-methylphenidate ingredients.
4. Subjects with an estimated intelligence quotient (IQ) \< 80.
5. Subjects are taking a concomitant medication (ex: Monoamine Oxidase Inhibitor (MAOI)) that is likely to interfere with safe administration of methylphenidate within 14 day prior to the study treatment initiation.
6. Subjects are joining other clinical studies and receiving any other investigational medical products within 30 days prior to the study treatment initiation.
7. Subjects have glaucoma (narrow angle glaucoma), on-going seizure disorder, or other psychotic disorder.
8. Subjects have chronic tics, Tourette's syndrome, or a family history of Tourette's syndrome.
9. Subjects have clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract.
10. Subjects/caregivers are (in the case of subjects whose parents/caregivers were to fill out the study questionnaires) with drug or alcohol abuse/dependence within the prior 6 months.
11. By the investigators' discretion, subjects with serious or unstable medical illness that will interfere with the evaluations of study efficacy and safety.
12. In the investigators' opinion, subjects cannot understand or follow the instructions given in the study.
13. Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
B: Inclusion Criteria:

* Any ADHD subtype, determined by KSADS interview (Kaufman, Birmaher et al. 1997). Comorbidity will likewise be allowed, to ensure representation.
* Signed informed consent and assent
* Clinical Global Impressions - Severity for ADHD (CGI-S-ADHD) rating is greater than or equal to 4
* Findings on physical exam, laboratory studies, vital signs, and ECG are judged to be normal for age
* Pulse and blood pressure are within 95% of age and gender mean
* Able to complete study instruments and swallow capsules
* Willing to commit to the entire visit schedule for the study, including at least one visit to UIC Medical Center.

Exclusion Criteria:

* Previous diagnosis of mental retardation
* Non-responder to either medication at the doses offered in the study in an adequate trial
* Must not have experienced disabling adverse effects with either medication
* Concomitant psychotropic medications are required or medications which might have a CNS effect
* Any other medical condition which represents a contraindication for either treatment is present
* History of alcohol or drug abuse in the past 3 months, or a positive urinary toxic screen on initial evaluation that is not explained by a time-limited medical circumstance
* Females of childbearing age who are sexually active, do not use acceptable birth control (double protection method), and after counseling, are unwilling to do so
* History of allergic reactions to multiple medications
* A history of psychosis
* Diagnosis of bipolar disorder
C: Inclusion Criteria:

* Male and female subjects aged 6-12 years, inclusive.
* Subjects meeting the DSM-IV criteria for primary diagnosis of ADHD-Combined type, or predominantly hyperactive-impulsive subtype, as established by the K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version). If a DSM-IV-defined ADHD diagnosis is difficult to establish due to possible co-morbidity, the subject will not be enrolled into the study.
* Subjects should be on a stabilized total daily dose or nearest equivalent of 40-60 mg methylphenidate or 20-30 mg of d-methylphenidate for at least two weeks prior to Screening visit.

Exclusion Criteria:

* Subject or subject's guardian unable to understand or follow instructions necessary to participate in the study.
* Diagnosed with or history of a tic disorder or Tourette's syndrome.
* History of seizure disorder.
* The presence of a known medical condition that would preclude the use of methylphenidate.
* A history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurological disease.
* ALT (Alanine Amino Transferase), AST (Aspartate Amino Transferase), GGT (Gamma glutamyl transferase) or serum creatinine greater then 2X the ULN (Upper Limit of Normal) at Screening.
* A history of psychiatric illness or substance use disorder (e.g., schizophrenia, bipolar disorder, autism, abuse or dependence, depression, severe Conduct Disorder or severe Oppositional defiant disorder)
* Subjects who have participated in an investigational trial within the past 4 weeks (28 days)
* Subjects who are currently taking antidepressants or other psychotropic medication.
* Subjects who have initiated psychotherapy during the three months prior to randomization.
* Subjects with a positive urine drug screen.
* Subjects who have a history of poor response or intolerance to methylphenidate or d-methylphenidate.

Other protocol-defined inclusion/exclusion criteria may apply
D: Inclusion Criteria:

* Age: 8 -17
* BD type I or II comorbid with ADHD
* Reduction of maniac symptoms (30% reduction in the YMRS scores and/or CGI scores ≤ 2)while using aripiprazole during a previous study (NCT00116259)without improvement of ADHD symptoms (reduction in ADHD symptoms \< 30% in the SNAP-IV). Those receiving placebo in the previous protocol will receive a 6- week open label treatment with aripiprazole. The same threshold for reducing maniac symptoms and absence of response in ADHD symptoms will be used.

Exclusion Criteria:

* IQ \< 70
* Pregnancy or absence of a contraceptive method in fertile girls
* Diagnoses: pervasive development disorder, schizophrenia, drug abuse or dependency
* Risk of suicide or homicide
* Clinical condition that might interfere in the study
* Known sensibility to aripiprazole

Answer: C