Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Open International Multicentre Long-Term Follow Up Study to Evaluate Safety of Prolonged Release OROS Methlyphenidate in Adults With Attention Deficit Hyperactivity Disorder
Brief Summary: Trial 42603ATT3004 is an open-label extension study to clinical trial 42603ATT3002 (NCT00246220). In trial 42603ATT3002 the efficacy and safety of OROS methylphenidate was assessed in adult subjects with Attention Deficit Hyperactivity Disease (ADHD). ADHD is a developmental disorder beginning in childhood and characterized by developmentally inappropriate inattention, hyperactivity and impulsiveness. Data on the number of adult patients with ADHD is limited, but it is estimated that approximately 50% of children with ADHD will have symptoms also in adhulthood. The drug tested in this trial is OROS methylphenidate. The active ingredient is methylphenidate and the tablet is designed to release the active ingredient gradually to ensure an effect, which lasts up to 12 hours. Trial 42603ATT3002 consisted of a 5-week period, where subjects were assigned to either receive placebo (empty drug) or one out of three different dosages of OROS methylphenidate. This 5-week period was followed by a 7-week period, where patients received OROS methylphenidate at their optimal dose. In study 42603ATT3004, subjects who complete 42603ATT3002 are followed for a period of at least 52 weeks to evaluate safety and tolerability of OROS methylphenidate in patients who are treated with OROS methylphenidate over a long period of time.

Amendment: At the end of the open-label period of the present study 42603ATT3004, patients are enrolled into a double-blind placebo-controlled period, which lasts an additional 4 weeks. The purpose of this double-blind placebo-controlled period is to evaluate the maintenance of effect under continued treatment with OROS methlyphenidate in comparison to treatment cessation in those patients, who are randomized into the placebo-group.


Options:
A: Inclusion Criteria:

* Patient has completed study CR002479 (42603ATT3002), according to protocol
* Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV)1 and confirmed by the Conners' Adult ADHD Diagnostic Interview for DSM IV (CAADID)
* Healthy on the basis of physical examination, medical history
* Patient is able to comply with the study visit schedule and willing and able to complete the protocol-specified assessments
* Amendment (double-blind placebo-controlled period): written informed consent
* patient must have completed at least 52 weeks of open-label treatment and must have been on a stable daily dose of (PR) OROS methlyphenidate prior to inclusion to this phase

Exclusion Criteria:

* Patient is known to be a non-responder to methylphenidate, or patient has a child known to be a non-responder to methylphenidate
* Allergy or hypersensitivty to methlyphenidate
* Any clinically unstable psychiatric condition including but not limited to the following: acute mood disorder, bipolar disorder, acute obsessive-compulsive disorder (OCD), Anti-social personality disorder, borderline personality disorder
* Use of other anti-depressants (unless patient has been on a stable dosage during the 42603ATT3002 trial, in which case treatment may continue as long as dosage remains unchanged for the duration of the study) or mood stabilisers (e.g. anti-epileptics, lithium)
* Any medication likely to interfere with safe administration of methylphenidate, or any conditions that are contraindicated for use of methlyphenidate
B: 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.
C: Inclusion Criteria:

* Case group:

Case group I: The cases with childhood ADHD diagnosis diagnosed as ADHD after interview Case group II: The cases with sufficient ADHD symptoms for diagnosis as DSM-IV ADHD at childhood but never assessed or treated for ADHD in childhood

* Control group：The subjects without the DSM-IV-TR diagnosis of ADHD or any major psychiatric disorders.

Exclusion Criteria:

* Comorbid with DSM-IV-TR diagnosis of pervasive developmental disorder, schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorder, organic psychosis, schizotypal personality disorder, bipolar affective disorder, severe anxiety disorder(such as OCD, ASD or PTSD) and mental retardation.
* In the major depressive episode, comorbid with severe anxiety disorders or during substance intoxication or withdrawal at the time of evaluation.
* With neurodegenerative disorder, epilepsy, involuntary movement disorder, congenital metabolic disorder, brain tumor, history of severe head trauma, and history of craniotomy.
* With visual or hearing impairments, or motor disability which may influence the process of neuropsychological assessment.
D: 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.

Answer: A