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

Completed · Not applicable · Has a placebo group

Conditions studied: Autistic Disorder

In brief

The primary study objective is to evaluate the efficacy of Vayarin\_005 on ASD related symptoms in children.

Key facts

Study ID

NCT02222285

Run by

Enzymotec

People needed

56

Starts

2014-08-01

Expected to finish

2017-10-01

Last updated by the study team

2018-04-11

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females, ages 6-17 inclusive
• Must have a valid diagnosis of autism spectrum disorder via a clinical review of the DSM-IV, confirmed by Autism Diagnostic Observation Schedule (ADOS)
• Clinical Global Impression Scale of Severity of Illness for Pervasive Developmental Disorders (CGI-S-PDD) rating of 4 or higher (moderately ill or worse)
• IQ >50 evaluated by KBIT-2 or Stanford Binet Fifth Edition
• Able, and likely to fully comply with the study procedures and instructions
• Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.
• Have normal physical examination and laboratory test results at screening. If abnormal, the finding(s) must be deemed clinically insignificant by the study Clinician.
• Parents or legal guardian must be able to read, write and speak English
• Parents or legal guardian have given written informed consent to participate in the study

You may not qualify if…

• The subject is significantly underweight under the 5th percentile or obese above the 95th percentile
• 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.
• Patients with any primary psychiatric diagnosis other than autism at screening or a known genetic syndrome(s) that cause autism.
• Suspected or established CNS injury
• 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
• Use of alpha-agonists, or ADHD medications 4 weeks prior to study initiation and throughout the study
• Use of dietary supplements, 60 days before study initiation and throughout the study
• Change in educational/behavioral interventions within one month prior to participation or during the study
• A known comorbid psychiatric diagnoses of bipolar I disorder, suicidality, or substantial psychotic disorder.
• Subject who has participated in another clinical trial within 30 days of screening for this trial and/or any experimental treatment for this population
• Current history of physical, sexual, or emotional abuse
• History of alcohol or substance abuse as defined by DSM-IV criteria
• Consumption of >250 mg/day of caffeine
• History of allergic reactions or sensitivity to marine products and soy
• Has any illness which may jeopardize the participants' health or limit their successful trial completion.
• Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety

Where it is running

• Institute of Neurology and Neurosurgery at St. Barnabas — Livingston, New Jersey, United States
• Spectrum Neuroscience and Treatment Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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