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:

* 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
B: Inclusion Criteria:

* Male and Female
* 18 to 55 years old
* Meet Diagnostic and Statistical Manual-IV (DSM-IV), Autism Diagnostic Observation Schedule(ADOS), and Autism Diagnostic Interview-Revised (ADI-R) standards for Autism Spectrum Disorder or Aspergers Syndrome
* Have a high, normal or near normal Intelligent Quotient
* Speak and Understand English fluently

Exclusion Criteria:

* Born prior to 35 weeks gestational age
* Any primary psychiatric diagnosis other than autism at the time of screening
* Medical history of neurological disease
* Medical history of known MRI/structural lesion of the brain
* Patients who are pregnant
* With a medical condition that might interfere with the conduct of the study, confound interpretation of study results or endanger their own well being
* With evidence or history of malignancy or any significant hematological, endocrine, cardiovascular, respiratory, renal, hepatic or gastrointestinal disease
* Taking psychoactive medications
* Who plan to initiate or change nonpharmacologic interventions during the study course
* Who are unable to tolerate venipuncture procedures for blood sampling
C: Inclusion Criteria

* Autism based on DSM-IV criteria
* IQ \> 35
* Medically fit for the study in the judgment of the study officials

Exclusion Criteria

* Prior administration of secretin
* Acute or chronic pancreatitis
* Use of anticholinergics within 72 hours of study entry or anticipated need for anticholinergics during study
* Allergies to pork products
* Use of investigational drug within 1 month of study entry
* Change in any medication or other therapeutic modality being used to treat any neurodevelopmental or gastrointestinal symptoms of the underlying autism disorder within 1 month of study entry
* Any medical condition which, in the judgment of the investigator, would make the patient unable to safely participate in the study or comply with all study procedures
* Any medical diagnosis which could account for autistic spectrum disorder (i.e., Rett syndrome, Fragile X, tuberous sclerosis, disintegrative disorder, epilepsy, Landau Kleffner, other mental retardation syndromes, or history of severe motor delays or current sensory or motor impairment such as cerebral palsy)
* Hearing or visual impairments
* Use of psychotropic medications (except for occasional symptomatic use for sleep, etc.) within 6 months of study entry
D: 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.

Answer: A