Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 40-week, Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy and Safety Study of Methylphenidate HCl Extended Release in the Treatment of Adult Patients With Childhood-onset ADHD
Brief Summary: This study will evaluate efficacy and safety of methylphenidate hydrochloride extended release compared to placebo in adult patients with childhood-onset attention deficit/hyperactivity disorder (ADHD).


Options:
A: Inclusion Criteria:

* Investigator determined diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria with symptomatology from childhood to adulthood, symptoms present before age seven years and continue to meet full DSM-IV criteria at time of assessment
* Diagnosis confirmed by the Adult ADHD Clinical Diagnostic Scale (ACDS) at Baseline and Adult ADHD Investigator Symptom Rating Scale (AISRS) score of 24 or greater as determined by the Investigator at Baseline
* Global Assessment of Functioning (GAF) Scale score of 41 to 60, inclusive, at Baseline
* Minimum weight of 100 lbs (45.4 kg) at Screening
* Negative urine drug test at the Screening and Baseline Visits when tested for drugs of abuse

Exclusion Criteria:

* Known to be non-responders to methylphenidate or other stimulants for the treatment of ADHD
* History of allergy, sensitivity or contraindication to methylphenidate or components of methylphenidate HCL extended-release tablets
* Coexisting medical condition or taking concomitant medication that would interfere with safe administration of methylphenidate in the Investigator's opinion
* Known structural cardiac abnormality
* Diagnosis of or family history of Tourette's syndrome, or motor or verbal tics
* history of seizures or a seizure disorder other than febrile seizures in childhood
* Glaucoma
* Uncontrolled hyperthyroidism or hypothyroidism
B: Inclusion Criteria:

* Adults with a diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) according to DSM-IV criteria
* ADHD symptoms from childhood to adulthood, with some symptoms present before age 7 years which continue to meet DSM-IV criteria at the time of assessment. (ADHD is not diagnosed if the symptoms are better accounted for by another psychiatric disorder.)

Exclusion Criteria:

* Patients known to be a non-responder to methylphenidate or known to have a child who is a non-responder to methylphenidate
* treated with any methylphenidate-containing medication within 1 month of starting the study
* have any clinically unstable psychiatric condition including, but not limited to the following: acute mood disorder, bipolar disorder, acute obsessive-compulsive disorder, anti-social personality disorder, borderline personality disorder
* family history of schizophrenia or affective psychosis
* patients with motor tics or a history of Tourette's syndrome, or with a substance abuse or dependence disorder, an eating disorder, or mental retardation
* using any medications which may affect the evaluation of study results
C: Inclusion Criteria:

* Patients with a physician-confirmed diagnosis of ADHD per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and the health care practitioner (HCP) has made the decision to prescribe an extended-release methylphenidate (ER MPH) product to the patient for potential improvement of symptoms throughout and later in the day, independent of this study.
* Patient must be 12 years of age or older.
* Patient must be eligible to receive Adhansia XR or osmotic- release oral delivery system methylphenidate (\[OROS MPH\] or Concerta) according to the US product labels; a patient must be eligible and willing to receive either drug, as randomization will assign them to a specific treatment group. Patient may be treatment-experienced or naïve to pharmacological therapy for ADHD, so long as all inclusion and no exclusion criteria are met.
* Patient must be willing to take only the assigned study medication per HCP instructions based on FDA label guidance for treatment of their ADHD for the first 2 months of the study (i.e. full titration period). Patients should not be on any other medication, or starting any new non-medication treatment, proven to have effect on ADHD in the first two months of the study.

Exclusion Criteria:

* Concurrent participation in an investigational study in which patient assessment and/or treatment may be dictated by a protocol.
* Patients with a true allergy to methylphenidate (MPH), amphetamine (AMP), or sympathomimetic amines, history of serious adverse reactions to MPH or AMP or be known to be non-responsive to MPH or AMP treatment.
* Patient is currently stable on their ADHD treatment regimen.
* Female patients of child bearing potential who are pregnant, planning on becoming pregnant or breastfeeding.
* Patient with any known conditions that are contraindicated for either Adhansia XR or OROS MPH (or Concerta) use, as documented in the US Full Prescribing Information, including patients with any known serious structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmias, or coronary artery disease.
* Patients with a known sensitivity to the food dye tartrazine (Federal Food, Drug, and Cosmetic Yellow No. 5).
* Suicidal Ideation

  * The Columbia-Suicide Severity Rating Scale (C-SSRS) will be administered at screening and at Month-2, Month-4, and Month-6, but also depends on the judgment of the HCP.
* Inability or unwillingness of the patient (or parent/guardian if patient is a minor) to complete the study-required electronic questionnaires and provide required information through electronic means.
D: Inclusion criteria:

1. Diagnosis of attention deficit/hyperactivity disorder (ADHD) which started in childhood
2. Female patients of childbearing potential must be practicing an acceptable method of contraception.

Exclusion criteria:

1. Patients with body mass index (BMI) less than 18.5 kg/m2 or more than 35 kg/m2
2. History of alcohol or substance abuse within the last six months.
3. History of seizures or use of anticonvulsant medication.
4. Any psychiatric condition that requires medication or may interfere with study participation.
5. Pre-existing cardiovascular disorders including severe hypertension, heart failure, myocardial infraction, etc.
6. Significant respiratory, hepatic, gastrointestinal, renal, hematological or oncologic disorder
7. Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma
8. Diagnosis or family history of Tourette's syndrome
9. Pre-existing cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke

Other protocol-defined inclusion/exclusion criteria may apply

Answer: D