Please select the eligibility criteria that correspond to the clinical trial below.
Title: Sleep and Tolerability of Extended Release Dexmethylphenidate vs. Mixed Amphetamine Salts: A Double Blind, Placebo Controlled Study (SAT STUDY)
Brief Summary: The purpose of this study is to evaluate how children and adolescents with Attention Deficit/ Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant medications used to treat ADHD, Adderall XR® and Focalin XR®. Another purpose of the study is to evaluate if there are differences in sleep and other side effects, such as changes in mood or loss of appetite, which can occur with stimulant medications. A third purpose is to determine if there are differences in the characteristics of individuals who respond better to either of the medications.

This research is being done because the investigators do not know if one of these two commonly used treatments is better tolerated than the other. Children and adolescents with ADHD often have a hard time sitting still, playing quietly, finishing things they start, paying attention, waiting their turn, and not distracting others. These medications improve these symptoms, but sometimes affect sleep, appetite, or mood.

It is hypothesized that at effective and frequently prescribed doses, Adderall will be associated with insomnia, more stimulant side effects, and decreased tolerability during an acute trial relative to Focalin.


Options:
A: 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.
B: Inclusion Criteria:

* Any ADHD subtype, determined by KSADS interview (Kaufman, Birmaher et al. 1997). Comorbidity will likewise be allowed, to ensure representation.
* Signed informed consent and assent
* Clinical Global Impressions - Severity for ADHD (CGI-S-ADHD) rating is greater than or equal to 4
* Findings on physical exam, laboratory studies, vital signs, and ECG are judged to be normal for age
* Pulse and blood pressure are within 95% of age and gender mean
* Able to complete study instruments and swallow capsules
* Willing to commit to the entire visit schedule for the study, including at least one visit to UIC Medical Center.

Exclusion Criteria:

* Previous diagnosis of mental retardation
* Non-responder to either medication at the doses offered in the study in an adequate trial
* Must not have experienced disabling adverse effects with either medication
* Concomitant psychotropic medications are required or medications which might have a CNS effect
* Any other medical condition which represents a contraindication for either treatment is present
* History of alcohol or drug abuse in the past 3 months, or a positive urinary toxic screen on initial evaluation that is not explained by a time-limited medical circumstance
* Females of childbearing age who are sexually active, do not use acceptable birth control (double protection method), and after counseling, are unwilling to do so
* History of allergic reactions to multiple medications
* A history of psychosis
* Diagnosis of bipolar disorder
C: Fathers Inclusion Criteria:

* Sign informed consent
* Be between 21-55 years old (inclusive) at the screening visit
* English-speaking
* At screening (after washout, if required) meet full DSM-IV criteria for ADHD, any subtype
* Current CGI-S-ADHD rating ≥ 4 and \< 7.
* Findings on physical exam (PE), laboratory studies, vital signs, and electrocardiogram (ECG) judged to be normal for age with no contraindications for MPH treatment.
* Pulse and blood pressure (BP) within 95% of age and gender mean
* Commit to the entire visit schedule for the study.
* Able to complete all study assessments.
* Fathers with comorbid mood/anxiety disorders which are effectively treated with antidepressants or anti-anxiety agents will be eligible for participation, provided this medication has not changed within 30 days, is well tolerated, and that current mood symptoms are not severe or associated with active suicidal ideation.

Father Exclusion Criteria:

* History of allergic reactions or severe negative response to study medications
* Active alcohol/substance abuse in the past 3 months or a positive urinary toxic screen on initial evaluation that is not explained by a time-limited medical circumstance.
* Current bipolar illness, schizophrenia, psychoses, or significant suicidal risk
* History of chronic or acute medical disorder for which stimulant therapy would be contraindicated (e.g., glaucoma, hypertension).
* Currently, (or within the past 30 days) receiving stimulant medication for ADHD.
* Father should not seek parent-based interventions during the course of the study, Weeks 1 - 8.

Child Inclusion Criteria:

* Sign assent if older than six.
* Be between the ages of 3-8.
* Symptoms of ADHD (Conners Hyperactivity Index or Attention \> 60).
* English speaking.
* No prior treatment with effective doses of stimulants.
D: 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.

Answer: B