Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-Group, Safety and Efficacy Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).
Brief Summary: The purpose of this study is to assess the safety and effectiveness of SPD465 compared to placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also look at how SPD465 affects the participants sleep and how they perceive their quality of life.


Options:
A: Inclusion Criteria:

* Primary diagnosis of ADHD
* Baseline ADHD-RS-IV score \>= 32
* Non-pregnant females of childbearing potential must comply with contraceptive restrictions.

Exclusion Criteria:

* Significantly underweight or morbidly obese
* Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Axis I disorders
* History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder
* Females who are pregnant or lactating
B: 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 based on a detailed psychiatric evaluation.
4. Subjects must have a baseline ADHD-RS-IV total score ≥28.
5. Subject is functioning at an age-appropriate level intellectually.
6. comply with all the testing and requirements.
7. Subject is able to swallow a capsule.
8. Subject has blood pressure measurements within the 95th percentile for age, gender, and height.

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, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder or other symptomatic manifestations.
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.
6. Subject has a positive urine drug result.
7. Subject weighs less than 50 pounds (22.7kg).
8. Subject is significantly overweight.
9. Subject has a history of seizures (exclusive of febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
10. Subject has any reported history of abnormal thyroid function.
11. Subject has taken another investigational product or taken part in a clinical trial within 30 days prior to Screening.
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. The female subject is pregnant or lactating.
14. Subject is well-controlled on their current ADHD medication with acceptable tolerability.
C: 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.
D: Inclusion Criteria:

* Primary diagnosis of ADHD
* Baseline ADHD-RS-IV score \>= 24
* Non-pregnant females of childbearing potential must comply with contraceptive restrictions

Exclusion Criteria:

* Significantly underweight or morbidly obese
* Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Axis I disorders
* History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder

Answer: A