Please select the eligibility criteria that correspond to the clinical trial below.
Title: Measurement of Cytogenetic Endpoints in Lymphocytes of Children Diagnosed With Attention Deficit/Hyperactivity Disorder (ADHD) and Treated With Methylphenidate or Adderall
Brief Summary: This study, conducted at Duke University in Durham, NC, will determine whether the drugs Adderall and methylphenidate affect the genetic material of children with attention deficit hyperactivity disorder (ADHD). One small study has shown that taking methylphenidate for ADHD may result in higher levels of certain types of changes to the genetic material contained in white blood cells. The changes seen are not directly linked to increased risk of disease, but indicate a possibility that other kinds of damage that may be linked to increased disease may result from taking methylphenidate. The study will also examine whether these types of changes might occur in children treated with Adderall .

Children between the ages of 6 and 12 with symptoms of ADHD may be eligible for this study. Candidates are screened with a medical history, psychiatric examination, IQ test, physical examination, and electrocardiogram. Parents and teachers complete questionnaires to rate the severity of the child's ADHD. Qualified children who are diagnosed with ADHD and who are appropriate candidates for treatment with either Adderall or methylphenidate-based drugs (e.g., Concerta, Metadate, Focalin, Ritalin or Ritalin LA) may be selected for this study.

At a baseline visit (Visit 0), parents complete questionnaires that rate the severity of their child's ADHD. The children have their vital signs checked (pulse, blood pressure, breathing rate, height, weight and temperature) and have a blood sample drawn. The children are then randomly assigned to treatment with either Adderall or a methylphenidate product. After the baseline visit, participants undergo the following tests and procedures:

Dose Optimization Visits (visits 1-4)

In the first 4 weeks of the study, the dose of methylphenidate or Adderall is adjusted weekly until doctors determine the dose strength that works best for the individual child. In addition, the following procedures are done at each visit:

* Child's vital signs are checked.
* Parents complete a questionnaire about the severity of the child's ADHD.
* Parent and child describe the impact of symptoms on the child's functioning.
* Parents complete forms about common side effects of the study drug.

Follow-up Visits (visits 5-6)

Children return to the clinic once a month to assess their health and further adjust their medication dose, if needed. The visits are similar to those during the dose optimization period, with the following additional procedures at visit 6:

* A blood sample is obtained to measure whether the medication has affected the child's genetic material.
* A physical examination is done to check child's health.
* Information is provided parents to assist in planning for child's treatment after the study.


Options:
A: Inclusion Criteria:

* Must sign informed consent.
* Male or female 6-12 years old.
* Negative pregnancy test.
* Meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition - Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD.
* No co-morbid illness that could affect safety, tolerability or interfere with participation.
* Blood pressure (BP) within the 95th percentile for age, gender, and height.
* Willing and able to comply with all the requirements defined in protocol.

Exclusion Criteria:

* Current controlled (requiring a restricted medication) or uncontrolled co-morbid psychiatric diagnosis (except Oppositional Defiant Disorder \[ODD\]).
* At risk for suicidal or violent behavior towards self or others.
* History of a suicide attempt.
* History of a structural cardiac abnormality or other serious cardiac problems.
* Non-responder to psychostimulant treatment.
* Is overweight.
* Seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
* Has Conduct Disorder.
* Known history of alcohol or other substance abuse within the last 6 months.
* Any abnormal thyroid function.
* A concurrent chronic or acute illness, disability, or other condition that might confound results of safety assessments.
* Has had treatment with any known liver altering agents within 30 days prior to Screening.
* Taking any excluded medication.
* Previous use of DAYTRANA.
* Taking other medications that have Central Nervous System (CNS) effects.
* Female subject is pregnant or lactating.
* Has any skin disease, or history of any chronic skin disease, skin cancer, skin manifestations of allergic disease, or other dermatologic conditions.
* Has sensitive-skin syndrome or has sensitivities to the ingredients in soaps, lotions, cosmetics or adhesives.
* Has clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites.
* A documented allergy, hypersensitivity or intolerance of methylphenidate (MPH) or any components found in DAYTRANA.
B: * INCLUSION CRITERIA:

Children of either sex, and of any ethnicity and economic status, age 6-12 years inclusive, who are diagnosed with ADHD, who are drug na ve, and who are determined by the study psychiatrist to be appropriate candidates for pharmacological therapy with either Adderall or methylphenidate-based drugs.

Child must be in good health as determined by medical history, physical examination and electrocardiogram (ECG).

EXCLUSION CRITERIA:

Children less than 6 years of age.

Children more than 12 years of age.

Children not determined to meet the comprehensive criteria for diagnosis of ADHD.

Children with co-morbid psychological conditions that would containdicate treatment with stimulant drugs.

Children who have previously undergone drug treatment for ADHD.

Children who have received diagnostic x-rays (not dental x-rays) within the past 3 months.

Female children who have had their first menstrual period.

Subjects who are not competent to provide consents.

Children determined by the study physician to be poor candidates for pharmacological therapy with Adderall or methylphenidate-based drugs.

Children with clinically significant abnormal electrocardiogram (ECG).
C: Inclusion Criteria:

* DSM-IV Diagnosis of trichotillomania
* DSM-IV diagnosis of ADHD
* Has not taken stimulants or alpha-adrenergic medications for more than 2 weeks prior to entering the study.

Exclusion Criteria:

* History of moderate or severe adverse event, related to MPH
* History of any psychotic disorder
* Current drug abuse, acute psychotic or affective disorder
D: Inclusion Criteria:

* Diagnosis of DSM-IV ADHD by K-SADS-PL and confirmed by clinical interview
* Clinical Global Impression-Severity score of at least 4 for ADHD
* Resided with primary caretaker for at least 6 months prior to study entry

Exclusion Criteria:

* History of autism, pervasive developmental disorder, chronic tic disorder, psychosis, or bipolar disorder
* Current major depression or panic disorder
* Systolic or diastolic blood pressure at screening greater than the 95th percentile or less than the 5th percentile for age and body mass index (BMI)
* Any medical condition that might make stimulant or alpha agonist therapy medically inadvisable
* Need for chronic use of other medications with central nervous system effects
* Pregnant, breastfeeding, or beyond menarche and has a positive urine pregnancy test
* History of structural heart defects, syncope, or fainting while exercising
* Clinically significant cardiac abnormality as determined by echocardiogram (ECG) at study entry
* Mental retardation as determined by clinical functional assessment and an IQ estimate of less than 70 based on Wechsler Adult Intelligence Scale (WAIS) subtests

Answer: B