Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 6-month, Open-label Extension to a 40-week, Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in the Treatment of Adult Patients With Childhood-onset ADHD
Brief Summary: This study will evaluate the long-term safety of methylphenidate hydrochloride extended release in adults with attention deficit/hyperactivity disorder


Options:
A: Inclusion Criteria:

Adults meeting DSM-IV-Text Revision criteria for ADHD, the Utah Criteria for ADHD, and experiencing at least moderate impairment (a score of 4 or greater on the CGI-Severity Scale for ADHD at both Screening and Baseline visits) will be enrolled. Other criteria include:

1. Subjects ages 18 to 65, inclusive;
2. Female subjects are eligible to enter and participate in this study only if:

   1. She is of non-childbearing potential; has a male sexual partner who is surgically sterilized; is on implant of levonorgestrel, injectable progesterone, or an oral contraceptive; has an intrauterine device (IUD); or is sexually inactive with a male partner.
   2. Or agrees to use a double barrier method of contraception (any combination of physical and chemical methods) and has a negative urine pregnancy test at screening interview.
3. Subject must be in general good health as determined by medical history, ECG, and other analysis that, in the judgment of the study physician, would confirm the patient's good health.
4. Subjects must read and write at a level sufficient to provide written informed consent and complete study-related materials.

Exclusion Criteria:

* Subjects will not be eligible for inclusion in this study if any of the following criteria apply:

  1. Subjects with other current DSM-IV Axis I Disorders including Current or lifetime history of psychosis, current bipolar disorder type I, current Major Depressive Disorder, and Current Anxiety Disorder (unless in the opinion of clinic physician ADHD is the primary disorder and causes the disability seen in the patient);
  2. Subjects with any other DSM-IV Axis II diagnosis so severe that it would suggest non-responsiveness to pharmacotherapy for ADHD or noncompliance with the protocol;
  3. Subjects at risk for suicide or a risk to harm others;
  4. History of Substance Dependence according to DSM-IV criteria within 3 months of screening;
  5. Subjects currently abusing illegal drugs or alcohol are excluded from the study;
  6. Positive urine screen for drugs of abuse at screening for patients who have a significant history of substance use but still meet criteria 4 and 5. Patients not at risk for substance abuse will not be given a urine drug screen;
  7. Subjects in whom stimulants would represent a risk such as those with a history of stimulant abuse,
  8. History of uncontrolled hypertension or significant cardiovascular disease;
  9. Any known or suspected significant medical or psychiatric illnesses (e.g., hepatic or renal insufficiency, pulmonary (asthma, COPD, etc), gastrointestinal, endocrine, neurological or metabolic disturbances that, in the judgment of the investigator, may impair interpretation of study results or constitute a significant safety concern in the context of the clinical trial;
  10. Medications, including health food supplements judged by the investigator to be likely to have central nervous system activity (for example, St John's Wort, gingko leaf, and melatonin), are not permitted during the study. If the subject is taking the medication prior to study entry, there must be a 7 day washout period prior to Visit 2. We will ask for an honest report of all medications consumed between visits. In the event a medication with psychoactive properties is consumed, the patient will be counseled regarding the use of prohibited medications;
  11. Use of any medication not considered acceptable by the clinical investigator or the medical monitor during the 7-day period before the start of the study (Day 1);
  12. Subjects with high BMI (\>38) and those with high adipose tissue concentrations in the hip as judged by the clinician.
B: 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.
C: Inclusion Criteria:

1. Completion of the 40-week core study CRIT124D2302 and Week 40 (End of Study) assessments or Patients who meet predefined criteria for treatment failure, were withdrawn from the core study, and have completed core-study week 40 assessments (Premature Discontinuation Visit)

Exclusion Criteria:

1. Patients who, during the core study, developed any psychiatric condition that requires treatment with medication or that may interfere with study participation and /or study assessments.
2. Patients who during the core study developed cardiovascular disorders.
3. Pregnant women.
4. Patients who developed seizures during the core study.
5. Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma.
6. Diagnosis or family history of Tourette's syndrome.
7. Patients who during the core study developed cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis and stroke

Other protocol-defined inclusion/exclusion criteria may apply
D: Fathers Inclusion Criteria:

* Sign informed consent
* Be between 21-55 years old (inclusive) at the screening visit
* English-speaking
* At screening (after washout, if required) meet full DSM-IV criteria for ADHD, any subtype
* Current CGI-S-ADHD rating ≥ 4 and \< 7.
* Findings on physical exam (PE), laboratory studies, vital signs, and electrocardiogram (ECG) judged to be normal for age with no contraindications for MPH treatment.
* Pulse and blood pressure (BP) within 95% of age and gender mean
* Commit to the entire visit schedule for the study.
* Able to complete all study assessments.
* Fathers with comorbid mood/anxiety disorders which are effectively treated with antidepressants or anti-anxiety agents will be eligible for participation, provided this medication has not changed within 30 days, is well tolerated, and that current mood symptoms are not severe or associated with active suicidal ideation.

Father Exclusion Criteria:

* History of allergic reactions or severe negative response to study medications
* Active alcohol/substance 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.
* Current bipolar illness, schizophrenia, psychoses, or significant suicidal risk
* History of chronic or acute medical disorder for which stimulant therapy would be contraindicated (e.g., glaucoma, hypertension).
* Currently, (or within the past 30 days) receiving stimulant medication for ADHD.
* Father should not seek parent-based interventions during the course of the study, Weeks 1 - 8.

Child Inclusion Criteria:

* Sign assent if older than six.
* Be between the ages of 3-8.
* Symptoms of ADHD (Conners Hyperactivity Index or Attention \> 60).
* English speaking.
* No prior treatment with effective doses of stimulants.

Answer: C