Please select the eligibility criteria that correspond to the clinical trial below.
Title: N/A
Brief Summary: OBJECTIVES: I. Evaluate the efficacy of fluoxetine on social and language deficits, global severity and compulsive dimensions of children and adolescents with autism.

II. Assess the effectiveness of this treatment regimen on neurocognitive deficits in this patient population.

III. Compare the baseline compulsive severity and treatment outcome in these patients.


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: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Meets diagnostic criteria for autism

--Prior/Concurrent Therapy--

Other:

* At least 3 months since prior electroconvulsive therapy
* At least 1 month since prior investigational drugs or treatment with any drug known to cause major organ toxicity
* At least 2 weeks since prior monoamine oxidase inhibitors
* At least 6 weeks since prior long acting phenothiazines
* At least 1 week since prior other psychotropic drugs
* No prior fluoxetine of 20 mg/day for 6 weeks
* At least 6 weeks since prior fluoxetine
* No concurrent use of terfenadine (Seldane) or astemizole (Hismanal)
* No concurrent electroconvulsive therapy or other psychotropic drugs (unless otherwise permitted)
* Prior participation in another serotonin reuptake inhibitor trial allowed

--Patient Characteristics--

Hematopoietic: No significant hematopoietic disease

Hepatic: No prior or concurrent liver disease

Renal: No prior or concurrent kidney disease

Cardiovascular:

* No significant cardiovascular disease
* No abnormal EKG

Neurological:

* No prior seizure disorder or high risk development of seizures
* No prior cerebrovascular disease
* No prior brain trauma

Other:

* Not pregnant or nursing
* Negative pregnancy test
* No unstable major medical illness or systemic disease
* No moderate or severe mental retardation and motor deficits (IQ less than 50)
* No family history of bipolar disorder
* No prior or concurrent other mental disorders (e.g., schizophrenia, schizoaffective, organic, or bipolar disorders)
* No significant autoaggressive behavior or serious suicidal risk
* No prior or concurrent gastrointestinal conditions
* No unstable endocrine disease (e.g., hypo or hyperthyroidism)
* No prior or concurrent malignancy
* Must be able to tolerate tapering of psychoactive medication
* No history of hypersensitivity or severe side effects to fluoxetine or other serotonin reuptake inhibitors
* No history of severe personality disorder or noncompliance
C: 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
D: Inclusion Criteria:

Autism/ADHD Group:

* DSM-IV diagnosis of autistic disorder, as per the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS)
* Child manifests current symptoms of ADHD

Autism/non-ADHD Group:

* Meets the diagnostic criteria for autism, as above, but does not meet the diagnostic criteria for ADHD

Exclusion Criteria:

In both groups, exclusion criteria will include:

* Sensory or motor deficits sufficient to interfere with testing (e.g., blindness, severe cerebral palsy)
* Serious neurological disorders (e.g., epilepsy, stroke)
* Down syndrome, fragile X syndrome, Tourette syndrome, or fetal alcohol syndrome
* Bipolar disorder or a family history of bipolar disorder in a first-degree relative
* Other serious psychopathology that resulted in psychiatric hospitalization (e.g., for psychotic episode). The investigators will screen for this using the Diagnostic Interview for Children and Adolescents (DICA)-IV, and getting a complete developmental/medical history
* Serious physical handicaps that would interfere with performance on laboratory tasks
* IQ less than 50 and greater than 130
* Verbal mental age (VMA) less than 36 months (to exclude participants unable to understand simple task instructions)

In the autism/ADHD group, further exclusion criteria apply to the MPH trial:

* History of intolerance to MPH
* Weight less than 20 kg or greater than 59 kg (less than 44 pounds or greater than 130 pounds)
* Concomitant use of dextroamphetamine preparations (Dexedrine, Dextrostat), mixed amphetamine salts (Adderall XR), other MPH preparations (e.g., Concerta, Metadate); venlafaxine, bupropion, atomoxetine, guanfacine, modafinil.
* Concomitant use of any herbal preparations
* Medical condition for which stimulants are contraindicated (e.g., high blood pressure)
* Past treatment failure on a methylphenidate trial

Answer: B