Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multi-centre, Randomized, Double-blind, Placebo-controlled, Two-period Cross-over, Exploratory Biomarker and Safety and Tolerability Study of a Single Dose of RO5028442 in Adult Male High-functioning Autistic Patients
Brief Summary: This multi-center, randomized, double-blind study will evaluate exploratory biomarkers and the safety and tolerability of a single dose of RO5028442 in adult male high-functioning autistic patients. In a cross-over design, patients will be randomized to receive either a single dose of RO5028442 or matching placebo with a washout period of 7-14 days. Anticipated time on study is up to approximately 9 weeks.


Options:
A: Inclusion Criteria:

* Age ≥ 12 and \< 26 years.
* Weight greater than 50 kg.
* Diagnosis of ASD
* Drug-refractory irritability, as defined as screening ABC Irritability subscale (ABC-I) score of ≥18 AND 1) failure of clinically adequate treatment trials of both aripiprazole and risperidone or 2) failure of at least three previous clinically adequate drug trials targeting irritability (one trial must include aripiprazole or risperidone), as confirmed by caregiver reports and medical record review when available.
* Stable dosing of all concomitant psychotropic medications (including those targeting irritability) for four weeks prior to screening visit and during the study.
* Presence of parent/guardian willing to serve as informant for behavioral outcome measures and shipping control sample for Extracellular Signal-Related Kinase biomarker (ERK) assay.

Exclusion Criteria:

* Current use of more than two concomitant psychotropic drugs targeting irritability.
* Current use of valproic acid.
* Current use of drugs with known interaction with riluzole
* Current use of drugs with concomitant glutamatergic or glutamatergic- modulating action medications.
* For female subjects of child bearing potential, a positive serum pregnancy test.
* History of pancreatitis.
* Hemoglobin less than or equal to 8.0 gm/dL.
* Neutropenia with absolute neutrophil count less than or equal to 1.0 K/mcL.
* Problems with kidney functioning, as assessed by lab work
* Any major chronic medical or chronic respiratory illness considered to be uncontrolled by the Principal Investigator.
B: Inclusion Criteria:

* Patients with a diagnosis of Autistic Disorder as defined by DSM-IV, confirmed by the team and supported with the Autistic Diagnostic Observation Schedule (ADOS)
* Male adults, 18 to 45 years of age
* IQ \> 70 (Wechsler Adult Intelligence Scale-Full scale)
* Body mass index (BMI) 18 to 35 kg/m2 inclusive
* Aberrant Behavior Checklist (ABC) - Irritability subscale score \</= 13

Exclusion Criteria:

* Positive urine test for drugs of abuse
* Alcohol and/or substance abuse/dependence during the last 12 months
* Positive for hepatitis B, hepatitis C or HIV infection
* Clinically relevant cardiovascular, renal, hepatic or hematologic disease or disorder
* Active inflammatory pulmonary disease
* History of epilepsy/seizure disorder (except for simple febrile seizures)
* Initiation of new or major change in psychosocial intervention within 4 weeks prior to randomization
* Treatment with any investigational agent within 90 days prior to screening
* History of hypersensitivity or allergic reactions
C: Inclusion Criteria:

* The patient meets current DSM-IV-TR diagnostic criteria for Autistic Disorder (defined in DSM-IV-TR) and also demonstrates behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems.
* Inpatient or outpatient status
* Others

Exclusion Criteria:

* The patient is currently diagnosed with another disorder on the autism spectrum in DSM-IV-TR, including Asperger's, Rett's Disorder, PDD-NOS, Childhood Disintegrative Disorder, or Fragile-X Syndrome.
* Patients who fall under a contraindication listed in the ABILIFY package insert
* Others
D: Inclusion Criteria:

* Participants: must meet the study definition for diagnosis of autistic disorder as determined by clinical diagnosis based upon DSM-IV criteria, the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS) performed at baseline 1. ADI-R will be conducted by trained study staff at Baseline 1 Visit. If the participant has had an ADI-R in the past 12 months, this will be accepted provided the person administering and scoring the test is site personnel validated for the study.
* Age 2 to less than 6 years, male and female.
* Parent/Legal Guardian/Caregiver must be able to understand , read and speak English
* Written Informed Consent.

Exclusion Criteria:

* Presence or history of neurological disorders, including seizure disorders (abnormal EEG without seizures will not be excluded), PKU, tuberous sclerosis, Rett syndrome, Fragile X syndrome, Down Syndrome and traumatic brain injury.
* Other medical or behavioral problems requiring medications which are centrally active.
* Clinical or laboratory evidence of renal or hepatic disease (SGPT, GGT \> 2 x normal value, and serum creatinine \> 1.5 x normal value).

Treatment with any medication known to alter the activity of the CYP3A4 enzyme including ketoconazole, itraconazole, grapefruit juice, erythromycin, clarithromycin, cimetidine, verapamil, diltiazem, rifampin, phenytoin, phenobarbital, or carbamazepine within the previous 2 months and for the duration of the study is prohibited.

* Use of centrally acting drugs during the 6 weeks prior or during the study. These drugs include but are not limited to neuroleptics, benzodiazepines, anticonvulsants and antidepressants. Shorter times may be considered depending on the half life of the drug.
* Prior treatment for periods longer than two weeks with buspirone or selective serotonin reuptake inhibitors. This includes herbal substances such as St John's Wort which have similar pharmacological actions.
* Known allergies to study medication.
* Unable to provide the required blood samples.

Answer: B