Please select the eligibility criteria that correspond to the clinical trial below.
Title: NWP06 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)- A Laboratory Classroom Study
Brief Summary: The objective of this study was to establish that an optimal dose of Quillivant XR oral suspension would result in a significant reduction in signs and symptoms of ADHD compared to placebo treatment in pediatric patients ages 6-12 years with ADHD.


Options:
A: Inclusion Criteria:

* Male and female outpatients 6 to 12 years of age.
* Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview.
* Participation in structured morning routine (e.g. school, camp, or other organized activities).

Exclusion Criteria:

* Mental retardation (IQ \<75).
* Subjects with a medical condition, or treatment that will either jeopardize subject safety or affect the scientific merit of the study.
* Subjects with moderate to severe dermatological atopy.
* Subjects with known structural cardiac abnormalities.
* Organic brain disorders.
* Seizure Disorder.
* Subjects with Tourette's syndrome, or a history of psychosis or bipolar disorder.
* Subjects with current comorbid psychopathology that in the investigator's opinion will warrant immediate treatment or will interfere with the safe execution of the protocol (i.e. Anxiety or Major Depressive Disorder rated as moderate on CGI).
* Subjects with a history of intolerable adverse effects or non-response to methylphenidate.
* Pregnant or nursing females.
B: Inclusion Criteria:

* Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition

Exclusion Criteria:

* Other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of ADHD
C: Inclusion Criteria:

* Children aged 7 through 12 in school.
* All subjects must meet DSM IV criteria for the diagnosis of ADHD of any subtype \[21\].
* Each subject must also satisfy the following criteria regarding the severity of ADHD symptoms: 1. ADHD must be viewed as clinically significant and worthy of treatment by medications as judged by the parent and the site investigator. Operationally, medication treatment will be considered indicated for any subject who has ADHD symptoms that significantly interfere with academic or social functioning and that have not improved (or are not expected to improve) sufficiently with non-pharmacological interventions (e.g., modifying the classroom environment, tutoring). 2. The site investigator's rating of global functioning on the C-GAS must yield a score of 70 or below. Scores below 70 on the C-GAS are designated as indicating abnormal function \[22\]. The score of 70 corresponds to the anchor point description: "Some difficulty in a single area, but generally functioning pretty well."
* Screen of Intelligence using the vocabulary and block design subtests of the Wechsler Intelligence Scale for Children-Third Edition indicates an estimated I.Q \> 70.
* Informed consent/assent signed. We will not enroll any child who does not want to participate.
* The designated school for each subject agrees to participate in the study by completing all required questionnaires and following all specified procedures.
* The child must be able to swallow the tablets and capsules used in this study.

Exclusion Criteria:

* Subjects with tic disorder of any type or tic symptoms, a primary diagnosis of major depression, pervasive developmental disorder, autism, any psychotic disorder, and mental retardation (based on current DSM criteria) will be excluded. We will not exclude subjects with obsessive-compulsive disorder, oppositional-defiant disorder or conduct disorder.
* The presence of a known medical condition that would preclude the use of MPH or clonidine.
* Known pregnancy. A urinary pregnancy test will be performed for all menstruating female subjects. Female subjects of child bearing potential will be advised not to become pregnant. In this circumstance, study medication will be tapered and discontinued and the subject will be terminated from the study. A urinary pregnancy test will be repeated at the end of the study. Subjects who request information regarding possible birth control mechanisms will be referred to their primary care physicians.
* Known presence of impaired renal function. A routine urinalysis will be performed for each subject to exclude signs of renal failure.
* Known active cardiovascular disease/anomaly, which would be a contraindication for the use of MPH or clonidine.
* Subjects may not receive any other medication for the treatment of ADHD. Treatment with MPH or other stimulants must be discontinued for at least 2 weeks prior to enrollment and treatment with other medications to treat ADHD (e.g., antidepressants, clonidine) must be discontinued for at least 6 weeks prior to enrollment.
* Subjects may not receive any other psychotropic medication (e.g., serotonin reuptake inhibitors), anxiolytics (e.g., clonazepam) or hypnotics. Any such medication must be discontinued at least 6 weeks prior to enrollment.
* Previous use of MPH or clonidine will be permitted.
D: Inclusion Criteria:

* Male or female from 6 to 12 years of age at the time of screening, inclusive.
* Diagnosis of ADHD by a Psychiatrist, Psychologist, Developmental Pediatrician, or a Pediatrician meeting diagnostic criteria for ADHD (DSM-IV). A Schedule for Affective Disorders and Schizophrenia for School Age Children (K-SADS)16 was administered on all subjects to assist in diagnostic process.
* A clinician-administered Clinical Global Impression of Severity (CGI-S) score of 3 or greater. An Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) score at screening or baseline greater than or equal to the 90th percentile normative values for gender and age in at least one of the following categories: the hyperactive-impulsive subscale, inattentive subscale or the total score.
* Subject must have been in need of pharmacological treatment for ADHD.
* Subjects taking a medication to control ADHD at the time of screening must have been experiencing suboptimal efficacy, a safety or tolerability issue or in need of a long-acting liquid formulation.
* For subjects taking any daily medication at screening aside from ADHD medication: parent or legal guardian agreed that there would be no elective changes in subject's medications during the study (10 weeks total).

Exclusion Criteria:

* Excluded comorbid psychiatric diagnoses: DSM-IV Axis I diagnosis (active) other than ADHD, with the exception of Specific Phobias, Learning Disorders, Motor Skills Disorders, Communication Disorders, Oppositional Defiant Disorder, Elimination Disorders, Sleep Disorders, and Adjustment Disorders.
* Clinically significant cognitive impairment as assessed in the clinical judgment of the Investigator. In cases where this was not clear, study staff were permitted to administer a Wechsler Abbreviated Scale of Intelligence (WASI)17 to estimate the intelligence quotient (IQ). Significant cognitive impairment for this protocol was defined as an estimated IQ below 80.
* Subjects with chronic medical illnesses including seizure disorder (excluding a history of febrile seizures), severe hypertension, thyroid disease, structural cardiac disorders, serious cardiac conditions, serious arrhythmias, cardiomyopathy, glaucoma, Tourette's Disorder, family history of Tourette's Disorder or tics.
* Use of monoamine oxidase inhibitors within 30 days of the screening visit.
* Use of any psychotropic medication (except sedative hypnotics prescribed as a sleep aid at a stable dose for at least 30 days prior to screening, at bedtime only). Use of stimulant medication for control of ADHD at screening was permitted if inclusion criterion number 6 was met.

Answer: D