An Exploratory, Double-Blind, Placebo-Controlled Study of the Medical Food Vayarin in Children With Autism Spectrum Disorder (ASD)

Inclusion Criteria:

1. Males or females, ages 6-17 inclusive

2. Must have a valid diagnosis of autism spectrum disorder via a clinical review of the
DSM-IV, confirmed by Autism Diagnostic Observation Schedule (ADOS)

3. Clinical Global Impression Scale of Severity of Illness for Pervasive Developmental
Disorders (CGI-S-PDD) rating of 4 or higher (moderately ill or worse)

4. IQ >50 evaluated by KBIT-2 or Stanford Binet Fifth Edition

5. Able, and likely to fully comply with the study procedures and instructions

6. Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to
participate in the study provided they do not meet any exclusionary criteria.

7. Have normal physical examination and laboratory test results at screening. If
abnormal, the finding(s) must be deemed clinically insignificant by the study
Clinician.

8. Parents or legal guardian must be able to read, write and speak English

9. Parents or legal guardian have given written informed consent to participate in the
study

Exclusion Criteria:

1. The subject is significantly underweight under the 5th percentile or obese above the
95th percentile

2. Clinically significant systemic illness including hepatic, renal, gastroenterological,
metabolic, respiratory, cardiovascular (including ischemic heart disease),
endocrinologic, neurologic, immunologic, or hematologic disease, as determined by the
study clinician.

3. Patients with any primary psychiatric diagnosis other than autism at screening or a
known genetic syndrome(s) that cause autism.

4. Suspected or established CNS injury

5. Change in dosage of psychiatric pharmacotherapy or other medications that have central
nervous system effects or that affect performance 4 weeks before study initiation and
throughout the study phase

6. Use of alpha-agonists, or ADHD medications 4 weeks prior to study initiation and
throughout the study

7. Use of dietary supplements, 60 days before study initiation and throughout the study

8. Change in educational/behavioral interventions within one month prior to participation
or during the study

9. A known comorbid psychiatric diagnoses of bipolar I disorder, suicidality, or
substantial psychotic disorder.

10. Subject who has participated in another clinical trial within 30 days of screening for
this trial and/or any experimental treatment for this population

11. Current history of physical, sexual, or emotional abuse

12. History of alcohol or substance abuse as defined by DSM-IV criteria

13. Consumption of >250 mg/day of caffeine

14. History of allergic reactions or sensitivity to marine products and soy

15. Has any illness which may jeopardize the participants' health or limit their
successful trial completion.

16. Any other reason that, in the opinion of the investigator, prevents the subject from
participating in the study or compromise the patient safety