Please select the eligibility criteria that correspond to the clinical trial below.
Title: Novel Pharmacological Strategies in Autism
Brief Summary: This study will determine the effectiveness of aripiprazole and D-Cycloserine in treating symptoms associated with autism in children.


Options:
A: Inclusion Criteria:

* Weight of at least 15 kg (33.75 lbs)
* Meets DSM-IV criteria for autistic disorder
* Outpatient
* Medication-free for at least 2 weeks prior to baseline for all psychotropic medications. More information about this criterion, including exceptions, can be found in the protocol.
* Clinical Global Impression Scale Severity score (CGI-S) of at least 4
* Irritability subscale of the Aberrant Behavior Checklist (ABC) score of at least 18
* An IQ of at least 35 or a mental age of at least 18 months
* In good physical health

Exclusion Criteria:

* Meets DSM-IV criteria for Asperger's disorder, Rett's disorder, childhood disintegrative disorder, any other pervasive developmental disorder (PDD), schizophrenia, psychotic disorder, or bipolar disorder
* Current or past history of alcohol or other substance abuse within 6 months of study entry
* Comorbid neurodevelopmental disorder with possible association to autism (e.g., fragile-X syndrome, tuberous sclerosis)
* A significant medical condition such as heart, liver, kidney, or lung disease, or a seizure disorder
* Pregnant
* Prior adequate use of aripiprazole. More information about this criterion can be found in the protocol.
* Evidence of hypersensitivity to aripiprazole
* History of neuroleptic malignant syndrome
B: Inclusion Criteria:

1. Male or female outpatients 18 to 60 years of age.
2. Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision. The diagnosis will be confirmed with Autism Diagnostic Interview-Revised and Autism Diagnostic Observation Schedule .
3. Have a Clinician's Global Impression-Severity score ≥ 4 (moderately ill) at Screening and Baseline.
4. If already receiving stable nonpharmacologic educational, behavioral, and/or dietary interventions, have continuous participation during the preceding 3 months prior to Screening and will not electively initiate new or modify ongoing interventions for the duration of the study.
5. Have normal physical examination and laboratory test results at Screening. If abnormal, the finding(s) must be deemed clinically insignificant by the Investigators.
6. The patient must be able to speak and understand English sufficiently to understand the nature of the study and to allow for the completion of all study assessments.
7. Have a normal Intelligence Quotient (\>70) supported by the Wechsler Abbreviated Scales of Intelligence.

Exclusion Criteria:

1. Patients born prior to 35 weeks gestational age.
2. Patients with any primary psychiatric diagnosis other than autism at Screening: a history of attention deficit hyperactivity disorder, bipolar disorder, psychosis, posttraumatic stress disorder, schizophrenia, or major depressive disorder.
3. Patients with a medical history of neurological disease, including, but not limited to, epilepsy/seizure disorder (except simple febrile seizures), movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal magnetic resonance imaging/structural lesion of the brain.
4. Pregnant female patients.
5. Patients with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. Patients with evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease.
6. Patients taking psychoactive medication(s) (e.g., stimulants, antidepressants, antipsychotics, antiepileptics, anxiolytics, clonidine).
7. Patients who plan to initiate or change nonpharmacologic interventions during the course of the study.
8. Patients unable to tolerate venipuncture procedures for blood sampling.
9. Patients who, in the Investigator's opinion, might not be suitable for the study.
C: Inclusion Criteria:

* Male or female children and adolescents aged 5-17 years, inclusive, at the time of screening.
* Judged by the investigator to be in good health at screening based upon the results of a medical history, physical examination, 12-lead ECG, and clinical laboratory test results.
* Patients must have a previous documented diagnosis of ASD by a medical or psychological professional.
* Patients must be assessed by the Investigator as being moderately to severely impacted due to ASD
* Patients who are taking psychotropic medication(s) should be on a stable regimen of no more than 2 medications for at least 4 weeks preceding study Screening and must maintain that regimen throughout the study. Psychotropic medications include (but are not limited to) antipsychotics, antidepressants, mood stabilizers, anxiolytics, and ADHD medications.
* Patients with a history of seizure disorders must currently be receiving treatment with a stable regimen of one or two AEDs, or must be seizure-free for 1 year if not currently receiving AEDs.
* Patients with seizures should be on a stable regimen for the 3 months preceding study enrollment of no more than 2 of the permitted anti-epileptic drugs (AEDs). Patients must remain on a stable AED dose throughout the study.
* If patients are receiving non-pharmacological educational, behavioral, and/or dietary interventions or therapies, they must be stable and have been doing so for 2 months prior to screening. Changes with school breaks are expected and do not apply.
* Patients must have a BMI of between 12-32 kg/m2 (inclusive).
* Females of childbearing potential and must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at all designated visits.
* Patients/caregivers agree to abide by all study restrictions and comply with all study procedures.
* Parents/caregivers must be able to read and respond to questions and questionnaires in English.
* Patients/caregivers must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.
* Parents/caregiver(s) must provide written consent to assist in study drug administration.
* In the Investigator's opinion, patients/caregivers are reliable and willing and able to comply with all protocol requirements and procedures (including scheduled visits and confinement periods).

Exclusion Criteria:

* Adolescent females who are pregnant, nursing, or planning a pregnancy. Females of childbearing potential and male patients with a partner of childbearing potential who are unwilling or unable to use standard acceptable methods of contraception (including abstinence, hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, or intrauterine device) for the duration of the study and for 1 month after the last dose of study medication.
* History of significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any compound or chemical class related to CBD (Epidiolex) or its ingredients.
* Exposure to any investigational drug or device \< 30 days prior to screening, or plans to take another investigational drug at any time during the study.
* Use of any THC or CBD-containing product within 4 weeks of Screening Visit, planned use during the study, or positive THC urine test at screening.
* Patient is using the following medications: clobazam (Onfi, Frisium), felbamate (Felbatol), vigabatrin (Sabril), or everolimus (Afinitor).
* Plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
* Patient has ALT, AST, total bilirubin, or creatinine levels ≥ 2 times the ULN, alkaline phosphatase levels ≥ 3 times the ULN, or Hct \<1.2 times the LLN as determined from screening safety laboratories.
* Severe or unstable symptoms of ASD that may interfere with the study outcome evaluations and interpretation of results.
* Suffering from acute or progressive neurological disease, psychosis, schizophrenia or any psychiatric disorder or severe psychiatric abnormalities that are likely to require changes in drug therapy or interfere with the objectives of the study or the ability to adhere to protocol requirements.
* Has suspected or confirmed cardiovascular disease.
* History of treatment for, or evidence of, drug or alcohol abuse within the past year.
D: Inclusion Criteria:

* Diagnosis of PDD (PDD-NOS, Asperger's Disorder, Autistic Disorder)
* Hyperactivity
* Between ages 5 years 0 months and 13 years 11 months.
* Weight \>/= 15 kg (33 lb)
* A mental age of at least 18 months

Exclusion Criteria:

* Prior failed treatment with an adequate trial of guanfacine in the last 2 years
* Concurrent treatment with another psychoactive medication

Answer: A