Please select the eligibility criteria that correspond to the clinical trial below.
Title: Long-term Safety and Effectiveness of OROS (Methylphenidate HCl) in Children With ADHD
Brief Summary: The purpose of this study is to evaluate the long-term safety and effectiveness of OROSÂ® Methylphenidate HCl (a central nervous system stimulant) in children with attention deficit hyperactivity disorder (ADHD).


Options:
A: Patients - Inclusion Criteria:

* Diagnosis: Children and adolescents with a non-organic and non-drug-induced psychosis, meeting the criteria for ICD-10 diagnoses: F20, F22-F29 and F30.2, F31.2 F31.5, F32.3 and F33.3. This is verified with a semi-structured psychopathological interview using K-SADS-PL (Kaufmann 1997) four weeks after inclusion into the trial.
* Psychopathology: Children and adolescents with psychotic symptoms, scoring ≥ 4 on at least one of the following PANSS items: P1 (delusions), P2 (conceptual disorganisation), P3 (hallucinations), P5 (grandiosity), P6 (suspiciousness/persecution) or G9 (unusual thought content); and a total PANSS score \> 60. The treating physician has decided to prescribe an antipsychotic compound.
* Age: 12-17 years (both inclusive).
* Sex: Both sexes are included.
* Previous treatment: Patients must be antipsychotic-naïve. The maximum accepted previous treatment with antipsychotic compounds is two weeks cumulatively, and during the two weeks prior to inclusion no continuous treatment and a maximum of four dosages in total can have been received.
* Somatic illness: No somatic contraindication to planned medication, documented by standard somatic examination
* Written informed consent.

Patients - Exclusion Criteria:

* Compulsory treatment: Patients that are compulsorily hospitalised against their will are excluded. If their status changes to voluntary hospitalisation, patients can be included. If the patient is already included in the trial and is briefly detained, confined, or subjected to other forceful treatment according to the Danish Psychiatric Care Act ('Psykiatriloven'), both the patient and parents have to agree to remain in the trial if exclusion is to be avoided. Compulsory treatment in the form of, e.g., brief forced immobilisation or single instances of forced medication, are not causes for exclusion.
* Diagnoses: Patients with drug-induced or organic psychosis, severe chronic somatic illness, or a history of severe head-trauma are not included. Patients that do not have psychotic symptoms but are prescribed antipsychotic treatment on the indication of, e.g., severe behavioural problems or tics are not included.
* Pregnancy: Pregnant or lactating patients are not included (a pregnancy test is undertaken at inclusion). Female participants, that are sexually active, must use safe contraception throughout the trial period (see section 6.4)
* Substance abuse: People with severe alcohol or drug abuse are not included. Possible abuse is monitored both by interviewing participants and by taking a urine sample at inclusion and at 4, 12 and 52 weeks follow-up (if there is suspicion of substance abuse), testing for the presence of cocaine, amphetamine, cannabis, opiates, metamfetamine (inclusive for extacy), and benzodiazepines. When severe abuse is suspected during the trial, an ad hoc urine sample is taken. Brief periods of large alcohol/cannabis intake are not a cause of exclusion from the trial; however, cognitive and other examinations are not carried out while patients are under the influence of drugs or alcohol.
* Aggravation: Patients may be excluded if there is a significant worsening of clinical state during the course of the trial (i.e., increases of 30% or more from baseline on the PANSS total score).
* Allergy and intolerance: Patients with allergy towards the investigational drugs, or is lactose intolerant are not included.
* Lack of informed consent.

Healthy volunteers - Inclusion Criteria:

* Matching: Healthy controls (n=100) are included, in the way that they are matched to the first 100 patients included in the study (i.e., corresponding to the number of patients required in each treatment group). They will be matched according to:

  * age;
  * sex; and
  * socioeconomic status (based on a combination of parental education and income, according to criteria from the National Institute of Public Health (earlier Danish Institute of Clinical Epidemiology, DIKE)).
* Informed consent.

Healthy volunteers - Exclusion Criteria:

* Psychopathology: People with a previous psychotic disorder (ICD 10, F20-F29 and F30.2, F31.2, F31.5, F32.3 and F33.3) or current psychiatric disorder (multiaxial axis 1) are not included. This is verified by diagnostic screening using K-SADS-PL at eligibility assessment before inclusion into the study of healthy controls. The presence of psychotic psychiatric diagnoses in first-degree relatives is also a cause for exclusion.
* Somatic illnesses: People with severe chronic somatic illness or a history of severe head-trauma are not included.
* Intelligence: People with known mild mental retardation (i.e., IQ between 50-70) prior to inclusion are excluded; however, if mild mental retardation is found during the study, participants are not excluded, since they must be considered a marginal part of the normal distribution. People with moderate to severe mental retardation (i.e., IQ \< 50) are excluded.
* Substance abuse: People with severe alcohol- or drug abuse are excluded. Possible abuse is monitored both by interviewing participants and by taking a urine sample at inclusion and at 4, 12 and 52 weeks follow-up (if there is suspicion of substance abuse), testing for the presence of cocaine, amphetamine, cannabis, opiates, metamfetamine (inclusive for extacy) and benzodiazepines. Brief periods of large alcohol/cannabis intake are not a cause of exclusion from the study; however, cognitive and other examinations are not carried out while participants are under the influence.
* Lack of informed consent.
B: Inclusion Criteria:

* Age between 6 to 16 years old. Body weight between 20 to 60 kg
* Meet ADHD criteria in tne Diagnostic and Statistic Manual of Mental Disorders, fourth edition (DSM-IV) through questionaire and interview
* Intelligence quotient (IQ) \>= 70
* Currently unmedicated or effectively medicated with immediately released methylphenidate (The maximum dosage no more than 60mg/d)
* The patient and the parent express their will to comply with the follow up including the clinical interview and all the test
* The parent or the guardian sign the written consent
* Can swallow the capsule

Exclusion Criteria:

* Have administered immediate release methylphenidate, OROS MPH or atomoxetine, but ADHD symptoms not improved.
* Bipolar I or II disorder, psychosis, or pervasive developmental disorder.
* Meet the DSM-IV anxiety disorder.
* Any seizure disorder (except for febrile convulsion) or electroencephalogram (EEG) abnormal associated with epilepsy, or currently taking anti-convulsion drugs.
* Depression disorder, tend to commit suicide, or comorbid depression symptoms which need immediate treatment.
* Tics disorder, or Tourette's syndrom（DSM-IV 307.23）, or family history of tics disorder.
* Narrow-angle glaucoma
* cardiovascular diseases, or any diseases may be deteriorated when the pulse or the blood pressure increased, including hypertension or those taking anti-hypertension drugs.
* Diseases significantly enhance the sympathetic nervous system activity, or taking sympathomimetic drug every day.
* Allergic to methylphenidate or atomoxetine, or serious allergic reaction to more than one drugs or adverse event to multiple drugs before.
* Serious gastrointestinal stenosis
* History of alcohol, drug or other substance abuse
* Those using unprescribed potential abuse drugs in screening.
* In the process of the trial, the patient need to take other psychotropic drug other than the experimental drugs, including health food with central nervous system (CNS) activity (e.g. melatonin).
* Might begin any structure psychological therapy addressed for ADHD in the process of the trial
* Have used other psychotropic drugs in the past 30 days, including monoamine oxidase inhibitor.
* Are participating other clinical trial.
* Have difficulty in following up in 8 weeks.
* Relatives of the investigator.
* Employee of Xi-an Jensen or Eli lilly company.
C: Inclusion Criteria:

* Patients who have successfully completed one of the following earlier ALZA studies: CR005992, C-97-033 (and then successfully completed C-98-011), CR005989, or CR005995, without significant drug-related adverse events
* whose primary care physician agrees that it is appropriate to participate in this study
* who agree to take only the OROS® (methylphenidate HCl) supplied and no other methylphenidate dosage form or other medications for the treatment of ADHD during the study
* who are able to comply with the study visit schedule and whose parent(s) and teachers are willing and able to complete the protocol-specified assessments
* who have normal urinalysis, hematological and blood chemistry values or, if values are outside the normal range, they are determined not clinically significant by the investigator

Exclusion Criteria:

* Patients having clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract
* having any coexisting medical condition or are taking any medication that is likely to interfere with safe administration of methylphenidate
* having a known hypersensitivity to methylphenidate
* having a history of high blood pressure or who have a blood pressure (systolic or diastolic) equal to or greater than the 95th percentile for age, gender and height
* if female, have begun menstruation
D: Inclusion Criteria:

1. Adolescent outpatients between 12 to 17 years of age (inclusive).
2. Subjects with the DSM-IV diagnosis of ADHD, as manifested in the clinical evaluation and confirmed by structured interview.
3. Subjects with sufficient current ADHD symptoms to warrant treatment, as measured by a Clinical Global Impression Severity Scale (CGI-S) score of greater than or equal to 4 (moderately ill); OR subjects already on Concerta who are judged to be responders (CGI of 1 or 2) and who tolerate treatment well.

Exclusion Criteria:

1. Any serious or unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, hypertension), endocrinologic, neurologic, immunologic, or hematologic disease.
2. Clinically significant abnormal baseline laboratory values
3. History of seizures
4. Active tic disorder
5. Pregnant or nursing females
6. Mental retardation (intelligence quotient \[IQ\] \< 75)
7. Organic brain disorder
8. Eating disorders
9. Psychosis
10. Current bipolar disorder (current episode)
11. Current depression \> mild (CGI-S \> 3)
12. Current anxiety \> mild (CGI-S \> 3)
13. Substance abuse or dependence within the past 2 months
14. Recent change in non-monoamine oxidase inhibitor (MAOI) antidepressants (\< 3 months)
15. Recent change in benzodiazepines (\< 3 months)
16. Concerta non-responder

Answer: C