Please select the eligibility criteria that correspond to the clinical trial below.
Title: Study Of Fluoxetine In Autism: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group 14-Week Study To Investigate The Effect Of Fluoxetine Orally Dissolving Tablet (ODT) On Repetitive Behaviors In Childhood And Adolescent Autistic Disorder.
Brief Summary: The purpose of this study is to assess the effect of fluoxetine orally dissolving tablets (ODT) on the repetitive behaviors core domain in children and adolescents with Autistic Disorder. The study will also investigate the effect of fluoxetine on the improvement of symptoms and the effects on daily living of the patient's family.


Options:
A: Inclusion Criteria:

* Meets DSM-IV criteria for autistic disorder, .
* CYBOCS-PDD score of at least 10 at screening.

Exclusion Criteria:

* Diagnosis of Asperger Syndrome or Pervasive Developmental Disorder Not Otherwise Specified, Rett Syndrome, Childhood Disintegrative Disorder.
* Patients planning to commence cognitive behaviour therapy during the period of the study or those who have begun cognitive behaviour therapy within 8 weeks prior to enrolment.
* Patients who are currently taking fluoxetine or who have previously taken it are not eligible for the study.

Other protocol-defined Inclusion/Exclusion criteria may apply.
B: Inclusion Criteria:

* Meets DSM-IV, ADI-R criteria for autistic disorder.
* Age 5-17 years.
* Outpatients
* Parent or legal guardian willing to sign informed consent.

Exclusion Criteria:

* Subject has been diagnosed with a psychotic disorder (such as schizophrenia) or a mood disorder, including depression or bipolar disorder (manic depression).
* Subject has caused visible harm to him/herself.
* Subject has an active seizure disorder or epilepsy (seizures within the past year).
* Subject has an unstable medical illness, including heart disease.
* Subject has experienced brain injury.
* Subject has a history of diabetes.
* Subject reports significant improvement of autism symptoms and behaviors to current medication or other therapies.
* Subject has a history of prior treatment with Aripiprazole of 5 mg/day or higher for 6 weeks.
* Subject lives in a far away area and/or does not have regular access to transportation to the clinical facility.
* Subject is a pregnant female or unwilling to use acceptable contraception if sexually active.
C: Inclusion Criteria:

* Diagnosis of an autism spectrum disorder (autistic disorder, Asperger's syndrome, and pervasive developmental disorder, not otherwise specified).
* Significant hyperactivity, inattention, or impulsivity as determined by a score on an investigator-administered ADHD Rating Scale (ADHDRS)-Home Version that is at least 1.5 standard deviations above the mean for age and sex
* Parent/caregiver's primary complaint about the child is inattention, hyperactivity, and/or impulsivity ("ADHD" symptoms)
* Symptoms present for 6 months prior to study entry
* Psychotropic drug-free for at least 2 weeks prior to starting study medication. This drug-free period will be 5 weeks for fluoxetine (Prozac).

Exclusion Criteria:

* Weighs less than 15 kg (about 33 pounds)
* Any another psychiatric disorder that may require a different treatment, including psychotic disorders, major affective disorders, obsessive-compulsive disorder, panic disorder, or substance-related disorders
* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of Rett's disorder or childhood disintegrative disorder
* Presence of extreme aggression or self-injury
* Currently taking an effective psychotropic drug
* Currently using other medications that may be unsafe to take with atomoxetine (e.g., potent CYP 2D6 inhibitors, intravenous albuterol, monoamine oxidase inhibitors\[MAO\])
* Inability to swallow study medication
* Presence of a medical condition that would make treatment with atomoxetine unsafe (e.g., unstable hypertension or cardiac disease, asthma requiring frequent treatment with albuterol, narrow angle glaucoma, pregnancy, etc.)
* Mental age of less than 18 months
* Previous adequate trial of atomoxetine
* Previous evidence of hypersensitivity or an allergic reaction to atomoxetine
* Clinically significant abnormalities in laboratory measures indicating an undiagnosed medical condition as determined by the study physician in discussion with the participant's primary care physician
* Clinically significant abnormalities on ECG as determined by a pediatric cardiologist
* Pregnant
* Initiation of a new psychosocial intervention within 90 days prior to starting study medication. Participants who have recently had a significant change in their psychosocial interventions will not be eligible until this intervention has been stable for 90 days in order to avoid confounding results of the study. Stable interventions (e.g., speech and occupational therapy) will be allowed to continue during the course of the study. Minor changes in ongoing treatment (e.g., missed therapy sessions due to holiday/vacation planned break in therapy due to school holidays) will not be considered significant.
D: 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.

Answer: A