Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary: The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.


Options:
A: Inclusion Criteria:

1. Subject is a male or female aged 6-12 years inclusive at the time of consent.
2. Females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to comply with any applicable contraceptive requirements of the protocol.
3. Primary diagnosis of ADHD: combined sub-type or predominantly hyperactive impulsive sub-type based on a detailed psychiatric evaluation.
4. Subject has a baseline ADHD-RS-IV score ≥ 28.
5. Intelligent Quotient (IQ) score of 80 or above on the Kaufman Brief Intelligence Test (KBIT).
6. Subject must be able to complete at least the Basic Test of the PERMP assessment.

Exclusion Criteria:

1. Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder
2. Subject has Conduct Disorder.
3. Subject has a documented allergy, hypersensitivity or intolerance to amphetamines.
4. Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
5. The subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine) in accordance with DSM-IV-TR criteria.
6. Subject weighs less than 50 pounds (22.7kg).
7. Subject is significantly overweight
8. Subject had a history of seizures during the last two years (exclusive of febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
9. Subject has any reported history of abnormal thyroid function.
10. Subject has taken another investigational drug or taken part in a clinical trial within the last 30 days prior to Screening.
11. Subject has a known history of structural cardiac abnormality, as well as any other condition(s) that may affect cardiac performance.
12. 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
13. Subject is taking other medications that have central nervous system (CNS) effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics (bronchodilators are not exclusionary).
14. The female subject is pregnant or lactating.
15. Subject is well controlled on their current ADHD medication with acceptable tolerability.
B: Inclusion Criteria:

* Age from 9.0 to 14.0.
* ADHD diagnosis following assessment at a child \& adolescent outpatient clinic.
* Clarification for stimulant treatment.

Exclusion Criteria:

* Moderate or severe mental retardation.
* Psychosis.
* Proven brain damage.
* Sensory deficits and/or motor impairments that make the individual in question unsuitable for the relevant tests.
* Epilepsy.
* The child has previously been prescribed stimulant medication or is being treated with such medication.
* The child commutes between parents or there are other factors that substantially reduce the possibility of obtaining reliable observations from parents (The child needs to live in one place through out the whole trial since otherwise might severely influence the child's behaviour and the observations).
C: Inclusion Criteria:

* Subject must be 18-55 years of age, inclusive at the time of consent.
* Female subjects must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to comply with any applicable contraceptive requirements of the protocol.
* Subject meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition; Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD (diagnostic code 314.00 and 314.01) established by a comprehensive psychiatric evaluation that reviews DSM-IV-TR criteria with at least 6 of the 9 subtype criteria met. The Adult ADHD Clinical Diagnostic Scale version 1.2 (ACDS v1.2) will be utilized as the diagnostic tool.
* Subject has a Baseline score of \> or equal to 28 using the Adult ADHD-RS with prompts.
* Subject must have a minimum level of intellectual functioning, as determined by an Intelligent Quotient (IQ) score of 80 or above based on the Kaufman Brief Intelligence Test (KBIT).

Exclusion Criteria:

* Subject has a current comorbid psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms. Comorbid psychiatric diagnoses will be established by the psychiatric evaluation that includes the Structured Clinical Interview for DSM-IV-TR disorders (SCID-I).
* Subjects who are currently considered a suicide risk, any subject who has previously made a suicide attempt or those who are currently demonstrating active suicidal ideation.
* Subject has a history of seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.
* Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, transient ischemic attack or stroke or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
* Subject has current abnormal thyroid function, as defined as abnormal Screening thyroid stimulating hormone. Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
* Subject has a history of moderate to severe hypertension or has a resting sitting systolic blood pressure \>139mmHg or diastolic blood pressure \>89mmHg.
* Subject has a documented allergy, hypersensitivity, or intolerance to amphetamines.
* Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
* Subject has glaucoma.
* Subject is taking other medications that have central nervous system (CNS) effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are monoamine oxidase inhibitors (during or within 14 days of test or reference product administration). Stable use of bronchodilator inhalers is not exclusionary.
* Subject is female and pregnant or lactating.
D: Inclusion Criteria:

1. Subject is a male or female aged 6-17 years inclusive at the time of consent.
2. Subject must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
3. Subject must have a Baseline ADHD-RS-IV total score ≥28.
4. Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and Baseline.
5. Subject is able to swallow a capsule.

Exclusion Criteria:

1. Subject has failed to respond to more than one adequate course (dose and duration) of stimulant therapy. One course must have been a long-acting formulation.
2. Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary.
3. Subject is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently, demonstrating active suicidal ideation.
4. Subject has glaucoma.
5. Subject weighs less than 22.7kg (50lbs).
6. Subject is significantly overweight based on Centre for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts at Screening. Significantly overweight is defined as a BMI \>97th percentile for this study.
7. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or methylphenidate.
8. Subject has a documented allergy, hypersensitivity, or intolerance to any excipients in the test or reference products.
9. Subject has a history of seizures (other than infantile febrile seizures), a tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.
10. Subject has a known history of symptomatic cardiovascular disease, advance arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
11. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
12. Subject is well controlled on their current ADHD medication with acceptable tolerability.
13. Subject has a pre-existing severe gastrointestinal tract narrowing (pathologic or iatrogenic).

Answer: D