Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study To Evaluate the Safety And Efficacy Of Prolonged Release OROS Methylphenidate Hydrochloride (18, 36 and 72 mg/Day), With Open-Label Extension, In Adults With Attention Deficit/Hyperactivity Disorder
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of three doses of prolonged-release methylphenidate (a central nervous system (CNS) stimulant) in adult patients with 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:

* Patients diagnosed with ADHD, confirmed with the Conners Adult ADHD Diagnostic Interview for Diagnostic and Statistical Manual, 4th edition (DSM-IV) (CAADID)
* Patients who meet the cutoff scores for the Conners Adult ADHD Rating Scale (CAARS-S:SV)
* Patients with a Clinical Global Impression - Severity (CGI-S) score of \>=4 out of 7
* Patients must have a body mass index between 18.0 and 35.0 (inclusive)
* Women must be postmenopausal for \>=2 years, surgically sterile, abstinent, or practice a double-barrier method of birth control in addition to any other forms of birth control
* Women of childbearing potential must have a negative pregnancy test at screening
* Men must agree to use a double-barrier method of birth control and to not donate sperm during the study and for 3 months after the last dose of study drug
* Female partners of male patients must be postmenopausal, surgically sterile, abstinent, or also use an effective method of birth control.

Exclusion Criteria:

* Patients with any current Axis I psychiatric disorder
* Patients with a diagnosis of autism or Asperger's syndrome
* Patients with motor tics or a family history or diagnosis of Tourette's syndrome
* Patients with a diagnosis of a primary sleep disorder
* Patients who are suicidal or have previously attempted suicide
* Patients with a history of substance abuse or dependence within 6 months prior to screening
* Patients who have taken any mood stabilizer, antipsychotic, antidepressant, or anxiolytic within 3 months prior to screening
* Patients who have started behavioral or cognitive behavioral therapy specifically for ADHD within 3 months prior to screening
* Patients who have not responded previously to treatment with a psychostimulant medication or to treatment with atomoxetine HCl or OROS methylphenidate HCl.
C: Inclusion criteria

The following inclusion criteria are to be met:

1. Male and female outpatients \> 18 years of age.
2. Participants will have a current DSM-IV diagnosis of alcohol dependence.
3. Participants will have signed a witnessed informed consent.
4. Participants must have been drinking a minimum of \> 14 drinks (females) or \> 21 drinks (males) on average per week over a consecutive 30-day period in the 90-day period prior to initiation of abstinence, and have two or more days of heavy drinking (defined as 4 drinks for females and 5 drinks for males) in the 90-day period prior to initiation of abstinence.
5. Participants must have had a minimum of 4 consecutive days (96 hours) of abstinence and have a CIWA \< 8 prior to randomization.
6. Participants can be abstinent for a maximum of 21 days prior to randomization.
7. Participants will have no more than 21 consecutive days of planned absence during the 16 week active treatment period.
8. Participants who are able to identify at least one "locator" person to assist in tracking the participant for follow-up assessment.
9. Participants who are able to speak and understand English.

Exclusion criteria

The following exclusion criteria rule out participants:

1. Participants who meet current DSM-IV criteria for bipolar disorder, schizophrenia, bulimia/anorexia, dementia, or a psychological disorder requiring medication.
2. Participants requiring concomitant therapy with any medications that pose safety issues (see Appendix B).
3. Participants with a current diagnosis of dependence on any drug except for nicotine, cannabis, and alcohol, or habitual caffeine use. If there is a positive urine screen the participant can be retested after the (metabolic) interval appropriate to that drug. If the second urine drug screen is positive the person is excluded.
4. Participants who meet DSM-IV criteria for opiate dependence or abuse within the past 6 months, chronic treatment with any opiate-containing medications during the previous month, or urine positive for opioids.
5. Participants who have significant medical disorders that will increase the potential risk of study treatment or interfere with study participation, and participants with sensitivity to study medications or related drugs as evidenced by adverse drug experience, especially with opiate-containing analgesics, opioid antagonists, or acamprosate.
6. Participants with abnormal AST or ALT (more than 3 times the upper limit of the normal range(ULN)) or elevated bilirubin (more than 10% above the ULN). Tests may be repeated if initial results are out of range.
7. Participants who are pregnant or nursing infant(s), and women of childbearing potential not using a contraceptive method judged by the investigator to be effective.
8. Participants who intend to engage in additional formal treatment for alcohol-related problems, or who intend to continue in current treatment for alcohol-related problems during the active treatment period. Self-help treatments are not considered formal treatment.
9. Participants who have had more than seven days of inpatient treatment for substance use disorders in the 30 days previous to randomization.
10. Participants who have prior use of study medication(s) in the last 30 days.

Any question concerning the interpretation of or application of the inclusion/exclusion criteria will be referred to the medical expert at the Coordinating Center. If he is unavailable, the question will be referred to the Chairperson of the Treatment Subcommittee.
D: 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

Answer: D