Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Controlled Trial of Sertraline in Young Children With Autism Spectrum Disorder
Brief Summary: This study is a control trial of sertraline (Zoloft) in children aged 2 to 5 years old inclusive with Autism Spectrum Disorder. The trial is six months long, and each participant will receive a series of tests at both the beginning and end of the study. The researchers hope to show improvements in language and social deficits.


Options:
A: Inclusion criteria:

* Age: 18-60
* Gender: All
* Language: Communicative in English
* Participants with a prior diagnosis of DSM-5 ASD at some point in their lifetime OR a DSM-4 diagnosis of Autism OR a DSM-4 diagnosis of Asperger's syndrome OR a DSM-4 diagnosis of Pervasive Developmental Disorder Not Otherwise Specified.
* Symptoms of irritability, agitation or aggression as reported by parent and/or participant
* Aberrant behavior checklist - Irritability Subscale (ABC-I) score of 16 or higher
* No changes in psychotropic medications within the past 14 days.
* Either lives with a primary caregiver or closely engaged with a primary caregiver who interacts with the patient daily
* BMI \> 17.5 and \< 45

Exclusion criteria:

* Age \< 18 or \> 60
* BMI \< 17.5 or \> 45
* Currently using tobacco or any nicotine products (transdermal, gum, e-cigarettes)
* Changes in psychotropic medication management within the past 14 days
* Previous allergy to transdermal patches
* Patients with heart rate \> 100 or \< 50 or known history of cardiac rhythm abnormalities
* Systolic blood pressure \> 150 or \< 95; diastolic blood pressure \> 90 or \< 50
* No symptoms of irritability, agitation, or aggression as reported by parent and/or participant
* ABC-I score of less than 16
* No primary caregiver, or primary caregiver unable to assist with rating scales
B: Inclusion Criteria:

* Be between the ages of 3 years 0 months and 17 years 11 months at the time of randomization
* Be diagnosed by clinician experienced in assessment of ASD with autistic disorder, Asperger's syndrome, or PDD-NOS using DSM-V-TR criteria
* Must have clinical diagnosis of ASD confirmed using the Autism Diagnostic Observation Scale (ADOS, Lord et al., 2001)
* Must have clinical diagnosis of ASD confirmed using the Autism Diagnostic Interview-Revised (ADI-R, Rutter, 2003). ASD criteria proposed by Risi (2006). Specifically, subject must be within 1 point of autism criteria on both social and communication domains of the ADI or meet autism criteria in one of these ADI domains and come within 2 points of autism criteria in the other
* Have a guardian who is able to provide informed consent
* If cognitively able, subject must be able to provide informed assent/consent

Exclusion Criteria:

* Have a known diagnosis of Rett Syndrome or Childhood Disintegrative Disorder, or have marked sensory impairment such as deafness or blindness
* Have active cardiovascular disease or renal disease that is not controlled by medication
* Subjects who are pregnant, lactating, or who refuse to practice contraception if sexually active
* Subjects who have had changes in allied health therapies, behavioral or educational interventions within the two months prior to randomization other than those associated with school holidays
* Subjects who have had changes in psychiatric medications within 4 weeks of randomization
* Subjects who have had previous chronic treatment with oxytocin
* Subjects who have caretakers who are unable to speak English, be consistently present at visits to report on symptoms, or are otherwise judged as unable to comply with the protocol by the data collection site team
* Subjects with active seizures within the 6 months preceding screening or baseline -added part way through study in response to subject death.
C: Inclusion Criteria

1. Male or female outpatients, 10-17 years of age inclusive.
2. Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition. Diagnostic and Statistical Manual (DSM-IV) criteria will be established by a clinician with expertise with individuals with ASD. Best estimate Diagnosis will be reached using DSM-IV criteria, the Autism Diagnostic Observation Schedule (ADOS-2) and the Autism Diagnostic Interview (ADI-R).
3. Have a Clinician's Global Impression-Severity (CGI-S) score ≥ 4 (moderately ill) at Screening.
4. Verbal and performance scale Intelligence Quotient (IQ) ≥ 70 (both subtests of the Wechsler Abbreviated Scale of Intelligence (WASI-I or WASI-II ≥ 70).
5. If already receiving stable concomitant medications affecting behavior, have continuous participation for 1 month prior to Screening (with the exception of fluoxetine, where a period of 6 weeks is needed), and not electively initiate new or modify ongoing medications for the duration of the study.
6. If already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, have continuous participation during the preceding 3 months prior to Screening, and not electively initiate new or modify ongoing interventions for the duration of the study.
7. Have normal physical examination and laboratory test results at Screening. If abnormal, the finding(s) must be deemed not clinically significant by the Treating Clinician.
8. Ability to speak and understand English sufficiently to allow for the completion of all study assessments.
9. Ability to obtain written informed consent from the participant, if developmentally appropriate. If a participant does not have the capacity to consent, ability to obtain assent (if developmentally appropriate), as well as written informed consent from their parent(s)/legal guardian.

Exclusion Criteria

1. Patients born prior to 35 weeks gestational age.
2. Patients with a primary psychiatric diagnosis other than ASD.
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 brain MRI/structural lesion.
4. Pregnant female patients, sexually active female patients on hormonal birth control and sexually active females who do not use at least two types of non-hormonal birth control.
5. 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 with one or more of the following: HIV, Hepatitis B virus, Hepatitis C virus, hemophilia (bleeding problems, recent nose and brain injuries), abnormal blood pressure (hypotension or hypertension), drug abuse, immunity disorder or severe depression.
7. Patients who are currently taking oxytocin or have taken intranasal oxytocin in the past with no response.
8. Patients with a sensitivity to oxytocin or any components of its formulation.
9. Patients unable to tolerate venipuncture procedures for blood sampling.
10. Patients in foster care for whom the province/state is defined as a legal guardian
D: Inclusion Criteria:

* Documentation of Autism Spectrum Disorder with Diagnostic and Statistical Manual for Mental Disorders-Fifth edition, criteria as well as a standardized autism assessment such as the Autism Diagnostic Observation Schedule or the Autism Diagnostic Interview-Revised.
* Subject between the ages of 24-72 months of age.
* A reliable parent or caregiver who can report the side effects and communicate effectively with the research team.
* Stable medications during the two months prior to enrollment.
* Currently receiving interventions in the community or school for Autism Spectrum Disorder

Exclusion Criteria:

* Current or past Selective Serotonin Reuptake Inhibitor treatment.
* Other serious co-morbid medical disorders affecting brain function and behavior, including uncontrolled seizures.

Answer: D