Status:
COMPLETED
Omega-3 Fatty Acids For Treatment Of Young Children With Autism (OMG)
Lead Sponsor:
Holland Bloorview Kids Rehabilitation Hospital
Collaborating Sponsors:
The Hospital for Sick Children
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
2-5 years
Phase:
PHASE2
Brief Summary
This is a pilot, randomized, placebo-controlled trial of omega-3 fatty acids in autism. Autism, originally described by Kanner in 1943, is among the most severe of neurodevelopmental disorders. It is ...
Detailed Description
Currently risperidone is the only medication approved the by Food and Drug Administration (FDA) for this disorder, and specifically for irritability associated with autism, although not all patients w...
Eligibility Criteria
Inclusion
- Male or female outpatients 2-5 years of age.
- Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV) criteria. DSM-IV criteria for an autism spectrum disorder, (Autistic disorder, Asperger syndrome or PDD-NOS) will be established by a clinician with expertise with individuals with ASD based on parent interview, Autism Diagnostic Observation Schedule (ADO) and Autism Diagnostic Interview (ADI-R)
- If already receiving stable non pharmacologic educational, behavioral, dietary and or/ natural health product interventions during the preceding 3 months prior to Screening, will not electively initiate new or modify ongoing interventions for the duration of the study unless the child's condition is worsening or their turn comes up on the treatment waiting list.
- Have normal physical examination and laboratory test results at Screening. If abnormal, the finding(s) must be deemed clinically insignificant by the Investigator.
- The parents must be able to speak and understand English sufficiently to allow for the completion of all study assessments.
Exclusion
- Patients born prior to 35 weeks gestational age.
- Patients with any primary psychiatric diagnosis other than autism at Screening. We are aware the most primary psychiatric disorders are unlikely to be diagnosed in this age group
- Patients with a medical history of neurological disease, including, but not limited to, epilepsy/seizure disorder (except simple febrile seizures), movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal MRI/structural lesion of the brain.
- Patients with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. Patients with evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease, or coagulation deficits.
- Patients taking psychoactive medication(s) (e.g.,stimulants, antidepressants, antipsychotics, antiepileptics, anxiolytics, clonidine).
- Patients that have been off pharmacotherapy for less than 6 weeks.
- Patients who are participating in another clinical trial
- Patients on anticoagulants
- Patients who know that they will initiate or change nonpharmacologic interventions during the course of the study.
- Patients unable to tolerate venipuncture procedures for blood sampling.
- Patients taking Omega-3 supplements who have not discontinued treatment for six weeks prior to entering into the study.
- Patients who have allergies to any of the ingredients in omega-3 (study product) or the placebo.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01248728
Start Date
November 1 2010
End Date
June 1 2014
Last Update
July 16 2025
Active Locations (1)
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1
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada, M4G 1R8