Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Laboratory Classroom Study to Evaluate the Safety and Efficacy of PRC-063 Compared to Placebo in Children (6-12 Years of Age) With ADHD
Brief Summary: This is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase 3 study to evaluate the safety and efficacy of PRC-063 in the treatment of ADHD in pediatric subjects between 6 to 12 years of age.


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:

* 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.
C: Inclusion Criteria:

* male and female volunteers
* 18-40 years old
* healthy
* body mass index between 5th and 85th percentile
* Caucasian
* non smoker or moderate smoker (\<10 cigarettes per day)
* able to understand, write, and read German

Exclusion Criteria:

* acute or chronic pain condition (except for mild day-to-day pain on \<5 days/month)
* previous (up to 5 days preceding the study) or current medications prescription or over-the-counter, especially analgesics
* symptoms of a clinically relevant illness in the 2 weeks before the first study day
* hypertension
* any known psychiatric condition
* abuse of alcoholic beverages, drug abuse
* known positive human immunodeficiency virus status
* any known medical condition which may interact with study medication, study objectives, or compliance of subject with study tasks
* participation in a clinical trial in the 4 weeks preceding the study
* known allergy against Midazolam
* known allergy against Fentanyl
* pregnancy or breast-feeding
* unable or unwilling to give informed consent
* unable or unwilling to follow investigator's instructions
* unable or unwilling to comply with study protocol
D: Inclusion Criteria:

* Diagnosis of ADHD
* Diagnosis of opposition defiant disorder or conduct disorder
* Score that exceeds the study threshhold on the standardized scale of aggressive behavior

Exclusion Criteria:

* Current psychosis
* Current major depression
* Current pervasive developmental disorder
* Current obsessive compulsive disorder
* Any other anxiety disorder as primary diagnosis
* Mental retardation

Answer: A