Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double-Blind Comparison of Concerta and Placebo in Adults With Attention Deficit Hyperactivity Disorder
Brief Summary: This is a double-blind, placebo-controlled study using daily doses of up to 1.3 mg/kg/day of Concerta in the treatment of adults with the DSM-IV diagnosis of attention deficit hyperactivity disorder (ADHD) (childhood onset). We hypothesize ADHD symptomatology in adults with DSM-IV ADHD will be responsive to Concerta treatment and Concerta-associated response of ADHD symptomatology in adults will be sustained over time.


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:

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
C: Inclusion Criteria:

1. Male and female outpatients older than 18 and younger than 55 years of age.
2. Subjects with the diagnosis of attention deficit hyperactivity disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview.
3. ADHD Symptom Checklist score \> 24.
4. Patients with past history of depression, bipolar disorder, anxiety disorder (including OCD) without current disorder for \> 3 months as ascertained through structured diagnostic interview and clinical exam.
5. Subjects treated for anxiety disorders and depression who are on a stable medication regimen for at least three months, and who have a disorder-specific CGI-Severity score ≤ 3 (mildly ill) and who have a score on the Hamilton-Depression and Hamilton-Anxiety rating scales below 15 (mild range).
6. Subjects with a past history of tics but tic free for \> 1 year.
7. Subjects with past history of substance use disorders but substance free for \> 6 months.
8. Subjects receiving non-MAOI antidepressants (e.g., SSRI's, bupropion, venlafaxine) or benzodiazepines who have been on a stable regimen for \> 3 months for any of the conditions listed above.

Exclusion Criteria:

1. Any clinically unstable psychiatric conditions including the following: acute psychosis, acute panic, acute OCD, acute mania, acute suicidality, bipolar disorder, acute substance use disorders (alcohol or drugs, sociopathy, criminality, or delinquency.
2. Any metabolic, neurological, hepatic, renal, cardiovascular, hematological, opthalmic, or endocrine disease.
3. Clinically significant abnormal baseline laboratory values which include the following:

   1. Values \> 20% above the upper range of the laboratory standard of a basic metabolic screen.
   2. Exclusionary blood pressure \> 140 (systolic) and 90 (diastolic).
   3. Exclusionary ECG parameters: QTC \> 460 msec, QRS \> 120 msec, and PR \> 200 msec. Subjects having ECG evidence of ischemia or arrhythmia as reviewed by an independent cardiologist.
4. Mental retardation (IQ \<75).
5. Organic brain disorders.
6. Seizures or tics in the last year.
7. Pregnant or nursing females.
8. Subjects with current adequate treatment for ADHD or a history of a previous adequate trial of Concerta.
9. Non-English speaking subjects will not be allowed into the study for the following reasons:

   1. the assessment instruments are unavailable and have not been adequately standardized in other languages;
   2. our clinical trials facility is located in Cambridge and not at the MGH main campus; thus translators are unavailable;
   3. even if such translation services were available, the assessments in the English language conducted by English-speaking clinicians and raters with English-speaking subjects are already extremely time-consuming, lasting many hours, making it unfeasible, unrealistic, and of dubious clinical validity to conduct them with a translator with non-English-speaking subjects;
   4. psychiatric questionnaires and evaluations are taxing, and adding the complexity of a translator has the potential to make the patient experience even more exhausting
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: C