Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of Concerta in Treating ADHD in Mothers of Children With ADHD
Brief Summary: This study involves a 7 week dose-response trial of Concerta™ methylphenidate for mothers of children with ADHD who have ADHD themselves. The aim of this study is to assess the efficacy of Concerta™ in improving adult ADHD symptoms and impairments (primary outcome), as well as observed and reported parenting (secondary outcome). The researchers hypothesize that Concerta™ will significantly decrease mothers ADHD symptoms and impairment, as well as improve observed and reported parenting


Options:
A: Inclusion Criteria:

Mother:

* Have ADHD or problems paying attention and concentration themselves
* Have a child 6-12 years old with ADHD or possible ADHD
* Be the child's biological mother

Exclusion Criteria:

* Any CURRENT Axis I disorder (including major depression, psychosis, and substance use disorders) but with the exception of minor depressive or anxiety disorders
* Use of Anti-depressant medication
* Mothers with severe tics or Tourette's syndrome, a history of seizures or abnormal EEGs, high blood pressure, or narrowing or blockage of the GI tract
* Any women pregnant or brest-feeding
B: 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and Week 40 (End of Study) assessments or Patients who meet predefined criteria for treatment failure, were withdrawn from the core study, and have completed core-study week 40 assessments (Premature Discontinuation Visit)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
C: 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.
D: 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

Answer: A