Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Fixed-Dose, Randomized, Double-Blind, Placebo-Controlled Study of LY2216684 in Pediatric Patients With Attention Deficit/Hyperactivity Disorder
Brief Summary: The primary purpose of your child's participation in this study is to determine whether LY2216684 can help pediatric patients with attention-deficit/hyperactivity disorder (ADHD); and assess the safety of LY2216684 and any side effects that might be associated with it.


Options:
A: Inclusion Criteria:

To be eligible for inclusion, each subject must fulfill each of the following criteria at the Entry visit:

* The subject participated in the antecedent SPD485-409 study, and a) completed all required study visits (Baseline through Visit 9) OR b) completed the 5 week Dose Optimization period without achieving an acceptable condition as defined by the antecedent SPD485-409 study.
* Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Entry.
* Subject's ECG results are within the normal range or not clinically significant at Entry as judged by the Investigator in conjunction with the central reader.
* Females must have a negative urine pregnancy test at Entry and agree to use acceptable contraceptives throughout the study period and for 30 days the last dose of IP.
* Subject and parent of legally authorized representative (LAR) are able, willing and likely to fully comply with study procedures and restrictions.
* Written, signed and dated informed consent to participate in the study must be given by the subject's parent or LAR, in accordance with the International Conference on Harmonisation (ICH), Good Clinical Practices (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures.
* There must be documentation of the subject's assent to participate in the study indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions. Failure to object is not to be considered assent.

Exclusion Criteria

Subjects will be excluded from the study if any of the following criteria are met at Entry:

* Subject was discontinued from SPD485-409 due to a protocol violation, non-compliance, AE, or a serious adverse event (SAE).
* Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Similarly, the subject will be excluded if he or she has any additional condition(s) that in the Investigator's opinion would prohibit the subject from completing the study or would not be in the best interest of the subject. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.
* Subject is taking any medication that is excluded.
* Female subject who is pregnant or lactating.
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:

* Patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for ADHD based on Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime (K-SADS-PL) prior to randomization.
* Patients must have an Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) total score at least 1.5 standard deviations above the age/gender norm prior to randomization. They must have a Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) score greater than or equal to 4 at both the patients screening visit, prior to randomization.
* Patients must have laboratory results; showing no clinically significant abnormalities.
* Patients must be of normal intelligence, as assessed by the investigator.
* Patients/parents must have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venous punctures and examinations required by the protocol.
* Patients of child-bearing potential agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug. Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a urine pregnancy test.

Exclusion Criteria:

* Patients who weigh less than 18 kg or greater than 75 kg at screening and at randomization.
* Female patients who are pregnant or who are breast-feeding. Patients who have a history of Bipolar I/ II, psychosis, or pervasive developmental disorder.
* Patients who have current motor tics or a diagnosis of Tourette's Syndrome.
* Patients with marked anxiety, tension, and agitation sufficient, to contraindicate treatment with extended-release methylphenidate.
* Patients with a history of any seizure disorder, known electroencephalographic (EEG) abnormalities in the absence of seizures.
* If the electrocardiogram (ECG) assessed at screening/prior to randomization shows an abnormality meeting one or more of the absolute exclusion criteria listed in the Pediatric ECG Alert Criteria must be excluded from the study.
* Patients who, in the opinion of the investigator, are at serious suicidal risk.
* Patients with a history of severe allergies to more than one class of medications, multiple adverse drug reactions, or known hypersensitivity to extended-release methylphenidate.
* Patients with a history of alcohol or drug abuse within the past 3 months prior to, or who are currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner that the investigator considers indicative of abuse.
* Patients who screen positive for drugs of abuse not prescribed by a physician cannot participate. Drug screen may be repeated at the discretion of the investigator, and the patient may be allowed to enter the study if the repeat screen is negative. All patients must have a negative drug screen before enrollment in the study.
* Patients who have a medical condition that would increase sympathetic nervous system activity markedly, or who are taking a medication on a daily basis that has sympathomimetic activity are excluded. Such medications can be taken on an as-needed basis.
* Patients with problems that would be exacerbated by increased norepinephrine tone, including a history of cardiovascular disease, thyroid dysfunction, glaucoma, urinary retention, or severe gastrointestinal narrowing.
* Patients who, at any time during the study, are likely to need psychotropic medications apart from the drugs under study.
* Patients who, at any time during the study, are likely to begin structured psychotherapy aimed at ADHD symptoms are excluded. Psychotherapy initiated at least 1 month prior to screening is acceptable.
* Patients who have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks prior to randomization.
* Patients with current or past history of clinically significant hypertension.
* Patients who are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug, or concurrently enrolled in any other type of medical research.
* Patients who have participated in a prior study of LY2216684.
D: Inclusion Criteria:

* Male and female outpatients 6 to 12 years of age.
* Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview.
* Participation in structured morning routine (e.g. school, camp, or other organized activities).

Exclusion Criteria:

* Mental retardation (IQ \<75).
* Subjects with a medical condition, or treatment that will either jeopardize subject safety or affect the scientific merit of the study.
* Subjects with moderate to severe dermatological atopy.
* Subjects with known structural cardiac abnormalities.
* Organic brain disorders.
* Seizure Disorder.
* Subjects with Tourette's syndrome, or a history of psychosis or bipolar disorder.
* Subjects with current comorbid psychopathology that in the investigator's opinion will warrant immediate treatment or will interfere with the safe execution of the protocol (i.e. Anxiety or Major Depressive Disorder rated as moderate on CGI).
* Subjects with a history of intolerable adverse effects or non-response to methylphenidate.
* Pregnant or nursing females.

Answer: C