Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Electroencephalography Study of the Effects of Psychostimulants on Dynamic Patterns of Cognitive Task-based Functional Connectivity in Youths With Attention Deficit Hyperactivity Disorder
Brief Summary: In the current study, we will administer three widely administered cognitive tasks while simultaneously measuring electroencephalography (EEG) in ADHD patients before and after methylphenidate immediate release (IR) treatment compared to placebo. In addition we will compare the effective connectivity dynamics to normal subjects. Using this novel network analysis approach, we will attempt to address the currently limited cognitive network literature. We will attempt to map the connectivity between the discrete brain regions during the execution of the tasks before and after treatment with methylphenidate IR. Comparison with healthy control subjects will enable us to determine whether the direction of methylphenidate induced changes in brain functioning (in youths with ADHD) will be toward or away from normal connectivity patterns. We will also examine whether network patterns differ between the healthy controls and the ADHD patients.


Options:
A: Inclusion Criteria:

1. Males or females greater than or equal to 6 and less than or equal to 12 years of age
2. Females who are non-pregnant and non-nursing
3. Females of child-bearing potential who agree to practice a clinically accepted method of contraception during the study and for at least one month prior to study dosing and one month following completion of the study. Acceptable contraceptive methods include abstinence, oral contraception, surgical sterilization (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), intrauterine device, or diaphragm in addition to spermicidal foam and condom on male partner, or systemic contraception (e.g. levonorgestrel-releasing implant)
4. Diagnosis of ADHD (any type: combined, predominately hyperactive impulsive type or predominately inattentive type) by a psychiatrist, psychologist, developmental pediatrician or licensed allied healthcare professional using the DSM-5 and confirmed by administration of a structured diagnostic interview using the K-SADS-PL
5. Ratings on the ADHD-RS-5 based on when the subject is not receiving treatment for ADHD, the subject must have ≥ 90th percentile normative value for gender and age in at least 1 of the categories: total score, inattentive subscale or hyperactive/impulse subscale
6. Unsatisfied with his or her current pharmacological therapy for treatment of ADHD or not currently receiving pharmacological therapy for ADHD. Inclusion of subjects who are naïve to pharmacological therapy for ADHD is permitted
7. Must be functioning at an age-appropriate level intellectually as determined by an intelligence quotient of ≥ 80 on a documented IQ assessment such as the WASI-II vocabulary and matrix reasoning components, or the KBIT-2
8. Must have the ability to complete the PERMP assessments
9. Have parental consent (signed informed consent form) and written or verbal assent from the subject
10. Subject and parent(s)/caregiver are willing and able to comply with all the protocol requirements and parent(s) or caregiver must be able to provide transportation for the subject to and from the analog classroom sessions

Exclusion Criteria:

1. Has blood pressure and pulse greater than the 95th percentile for age and gender
2. Has current or recent history (within the past 6 months) of drug abuse or dependence disorder in the subject or the immediate family or by someone living at the participant's' home or positive urine drug screen for stimulant medication (other than currently prescribed stimulant for the treatment of ADHD) or drugs of abuse at the screening visit
3. Has untreated thyroid disease, glaucoma, Gilles de la Tourette's disorder, chronic tics or a history of seizures during the last 2 years (except simple febrile seizures), a tic disorder (exclusive of transient tic disorder). Mild medication-induced tics are not exclusionary
4. Primary and/or comorbid psychiatric diagnosis other than ADHD with the exception of simple phobias, motor skill disorders, communication disorders, learning disorders and adjustment disorders so long as such disorder is judged not to interfere with study participation or the safety of the subject or other participants. Children meeting conduct disorder or oppositional defiant disorder criteria but without history of prominent aggressive outbursts that could interfere with study participation or the safety of the subject or other participants will be allowed to enroll at the discretion of the investigator
5. Subjects with a family history (first degree relatives) of sudden cardiac death require review and approval by the medical monitor for participation in the study
6. Has a current or recent history of hypertension, symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug
7. Has a concurrent medical condition that, in the opinion of the investigator, could cause participation in this study to be detrimental to the subject
8. Has used any investigational drug within 30 days of the screening visit
9. Has a known history of physical, sexual, or emotional abuse in the last year
10. Has a medical history of hepatitis A, B, C or human immunodeficiency virus, or tests positive for any of these at screening
11. Has a positive urine pregnancy test (if applicable) at screening
12. Has positive findings on C-SSRS for suicidal ideation or behaviors at screening.
B: Inclusion Criteria:

* Children and adolescents which are being considered for methylphenidate treatment and therefore referred to computerized cognitive tasks with and without methylphenidate IR use as part of their management

Exclusion Criteria:

* study group: Age fewer than 6 and above 18, history of seizure, head trauma, substance abuse or medication other than stimulants, inability to swallow pills.

Exclusion criteria

* control group: Age fewer than 6 and above 18, history of seizure, head trauma, substance abuse, current medication use. Current or lifetime psychiatric disorders.
C: Inclusion Criteria:

* Patient has completed study CR002479 (42603ATT3002), according to protocol
* Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV)1 and confirmed by the Conners' Adult ADHD Diagnostic Interview for DSM IV (CAADID)
* Healthy on the basis of physical examination, medical history
* Patient is able to comply with the study visit schedule and willing and able to complete the protocol-specified assessments
* Amendment (double-blind placebo-controlled period): written informed consent
* patient must have completed at least 52 weeks of open-label treatment and must have been on a stable daily dose of (PR) OROS methlyphenidate prior to inclusion to this phase

Exclusion Criteria:

* Patient is known to be a non-responder to methylphenidate, or patient has a child known to be a non-responder to methylphenidate
* Allergy or hypersensitivty to methlyphenidate
* Any clinically unstable psychiatric condition including but not limited to the following: acute mood disorder, bipolar disorder, acute obsessive-compulsive disorder (OCD), Anti-social personality disorder, borderline personality disorder
* Use of other anti-depressants (unless patient has been on a stable dosage during the 42603ATT3002 trial, in which case treatment may continue as long as dosage remains unchanged for the duration of the study) or mood stabilisers (e.g. anti-epileptics, lithium)
* Any medication likely to interfere with safe administration of methylphenidate, or any conditions that are contraindicated for use of methlyphenidate
D: Inclusion Criteria:

* Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
* Children's Global Assessment Scale rating of 41-70 at baseline (Screening Phase)

Exclusion Criteria:

* Subjects who are known to not respond to methylphenidate
* Have had adverse experiences from methylphenidate or hypersensitivity to CONCERTA or its components
* Have marked anxiety, tension or agitation
* Have glaucoma, ongoing seizure disorder, psychotic disorder, Tourette's disorder or family history of Tourette's disorder

Answer: B