Autism Spectrum Disorder > Docosahexanoic Acid

DHA for Autism

Recruiting in Palo Alto (17 mi)

Overseen By Sherie Novotny, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Rutgers, The State University of New Jersey

Trial Summary

What is the purpose of this trial?

Dr. Sherie Novotny of the Department of Psychiatry at UMDNJ-RWJMS and collaborators are starting a treatment trial to determine whether Docosa Hexanoic Acid(DHA), the major omega-3 fatty acid found in the brain and a component of fish oil, has any effects on the symptoms of autism. We propose to carry out a trial to test the effect of DHA compared to a placebo (a pill with no drug in it) on several aspects of autism in children and adolescents, in a 12-week clinical study with children or adolescents in the age group of 5-17 with a diagnosis of Autism Spectrum Disorder. Additionally this trial will study genes related to the therapeutic agent, DHA, and biomarkers related to DHA in the urine.

Eligibility Criteria

This trial is for children and adolescents aged 5-17 with Autism Spectrum Disorder. Participants must meet specific autism diagnostic criteria, be seizure-free for at least 6 months if applicable, and capable of giving consent through a guardian. Sexually active females must use birth control. Those with certain medical conditions or on recent psychoactive medications are excluded.

Inclusion Criteria

I am between 5 and 17 years old.

My EEG results were abnormal, but I haven't had any seizures.

Meets DSM-IV, ADI, and ADOS criteria for autistic disorder

Exclusion Criteria

I am not pregnant or nursing.

I am a woman who can have children and am not using effective birth control.

Subjects with any of the following past or present mental disorders: schizophrenia, schizoaffective disorder, major depressive disorder, bipolar I or II disorders or substance abuse disorders

Participant Groups

The study tests the effects of Docosahexanoic Acid (DHA), an omega-3 fatty acid found in fish oil, against a placebo over 12 weeks to see if it improves symptoms of autism. It also examines genetic factors related to DHA and its biomarkers in urine.

Group I: Docosa Hexanoic Acid Active Control 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Rutgers Piscataway, NJ

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey Lead Sponsor

References