Please select the eligibility criteria that correspond to the clinical trial below.
Title: Atomoxetine, Placebo and Parent Management Training in Autism
Brief Summary: The study will evaluate the effectiveness of atomoxetine (Strattera) with and without Parent Management Training (PMT) in children with Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDDNOS) who have symptoms of Attention Deficit Hyperactivity Disorder (ADHD). This is a double-blind placebo, parallel study where the atomoxetine will have a dose titration over a 6 week period. All children will be seen weekly during this titration period, with additional visits at Week 8 and Week 10. Families assigned to the PMT arm will have an additional weekly meeting with a clinician for a total of 9 PMT visits. PMT involves teaching parents to implement behavioral interventions with their children. Subjects who are clinical responders (ADHD Responders and Compliance Responders) from the 10 week study period will be followed every 4 weeks in a 24-week extension study. Subjects who are clinical nonresponders will continue in PMT if they received PMT during the double-blind phase, and they will receive an open trial of atomoxetine if they were on placebo during the double-blind phase. All subjects (responders and nonresponders) will be invited to participate in follow-up assessments every 4 weeks for 24 weeks after the completion of the double-blind phase.


Options:
A: Inclusion Criteria:

* Males or females ages 6 to 12 years
* Diagnosis of autistic disorder, according to DSM-IV-TR using Autism Diagnostic Interview-Revised and Autism Diagnostic Observation Schedule (modules 2 \& 3).
* A knowledgeable caregiver capable of providing reliable information about the patient's condition, able to attend all clinic visits with the patient
* Patients over age 12, only if they completed Study MEM-PK-21

Exclusion Criteria:

* Medical history of active epilepsy/seizure disorder except simple febrile seizures
* Participation in any other clinical investigation using an experimental drug within 30 days of the start of this study
B: 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.
C: Inclusion Criteria:

* Children 5 yrs to 14 years 11 mos with clinical diagnosis of Autism, Asperger's Disorder, or PDDNOS based upon the ADI-R and clinical evaluation by DSM-IV criteria,
* Mental age equal to or greater than 24 months,
* ADHD symptoms based upon the CASI and clinical confirmed diagnosis,
* CGIS-S rating of 4 or grater for ADHD symptoms,
* A mean item score of \>1.5 on both the Parent and Teacher (non-parent caregiver) SNAP-IV 18 ADHD symptoms or the 9-symptom hyperactive-impulsive subscale (symptoms must be cross-situational),
* Reliable care provider available to bring subject to clinic visits and weekly sessions.

Exclusion Criteria:

* DSM-IV diagnosis of schizophrenia, schizoaffective disorder psychotic disorder NOS,bipolar disorder, or major depression (if accompanied by a family history of bipolar disorder) based upon evidence of suicidality, CASI, and clinical interview/history,
* Prior failed adequate trial of atomoxetine,
* Use of other psychotropic medications that produce CNS effects,
* Diagnosis of bipolar disorder, major depression, hypertension, cardiovascular disease, narrow angle glaucoma, other significant physical illness,
* Pregnancy or sexually active females (intercourse in the past 6 months, reported by either the subject or caregiver),
* Currently on effective medication treatment for ADHD,
* Prior involvement in Parent Management Training or other similar program,
* Currently on albuterol or taking beta blockers,
* Taking supplements or other complementary medical treatments where dose cannot be held at current level for duration of study
D: Inclusion Criteria:

* Medically healthy outpatients between 6 and 12 years of age (cut off 12 years and 11 months)
* Intelligence Quotient \> 40
* Diagnosis of autism spectrum disorder based on the Autism Diagnostic Interview - Revised, Autism Diagnostic Observation Schedule, and DSM-IV criteria
* Clinical Global Impression severity rating of 4 or higher
* Care provider who can reliably bring subject to clinic visits, provide trustworthy ratings, and interacts with the subject on a regular basis
* Stable medications for at least 4 weeks
* No planned changes in psychosocial interventions during the trial
* Willingness to provide blood samples.

Exclusion Criteria:

* Diagnostics and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder
* Regular nasal obstruction or nosebleeds
* Active medical problems: unstable seizures, significant physical illness (e.g., serious liver, renal, or cardiac pathology)
* Sensitivity to preservatives (in particular E 216, E 218, and chlorobutanol hemihydrate)
* A genetic abnormality (e.g., Fragile X Syndrome)
* Significant hearing or vision impairments
* Habitually drinks large volumes of water
* Pregnancy, breastfeeding, or child birth within the last 6 months
* Sexually active females not using a reliable method of contraception.

Answer: C