Phase 2
N=38
Omega-3 Fatty Acids For Treatment Of Young Children With Autism (OMG)
Autism Spectrum Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01248728 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Change From Baseline in the Pervasive Developmental Disorder-Behavioral Inventory (PDDBI) - Autism Composite Score — -4.5; -6.4 units on a scale — p=0.5
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Omega-3 Fatty Acids (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Pervasive Developmental Disorder-Behavioral Inventory (PDDBI) - Autism Composite Score |
-4.5; -6.4 | 0.5 |
| PRIMARY Change From Baseline in the Behaviour Assessment System for Children (BASC-2) - Externalizing Problems Composite |
3.2; -3.0 | 0.02 sig |
| SECONDARY Number of Participants Classified as Responders by the Clinical Global Impression - Improvement (CGI-I) |
12; 12 | — |
| SECONDARY Change From Baseline in the Vineland Adaptive Behavioral Scales (VABS) - Adaptive Functioning Composite |
2.8; -0.2 | 0.09 |
| SECONDARY Change From Baseline in the Preschool Language Scale (PLS-4) - Total Language |
0.7; -0.6 | 0.6 |
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 a Pervasive Developmental Disorder (PDD) affecting social and communicative functions and is also characterized by repetitive behaviors/restricted interests. It is also frequently accompanied by significant aggression, self-injury, irritability and hyperactivity, making care for these individuals an even greater challenge for families or institutional settings. Autism severely impacts the affected individual and family members, causing life-long functional impairment. In this protocol the investigators will use the terms "autism" and "autism spectrum disorder (ASD)" interchangeably to refer to Autistic disorder, Asperger Syndrome and PDD-Not Otherwise Specified (NOS).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01248728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.