Omega-3 Fatty Acids Monotherapy in Children and Adolescents With Autism Spectrum Disorders

Study Overview
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Brief Summary
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The primary aim of this study is to examine the efficacy and tolerability of short-term omega-3 fatty acids monotherapy in youth with Autism Spectrum Disorders (ASD). The investigators hypothesize that Omega-3 fatty acids will be efficacious in improving the core and associated features of ASD in youth, and that Omega-3 fatty acids monotherapy will be safe and well tolerated by youth with ASD. The secondary aim of this study is to examine the neuropsychological effect of Omega-3 fatty acids monotherapy in youth with ASD. The investigators hypothesize that omega-3 fatty acids will be efficacious in improving cognitive functions in youth with ASD.

Official Title
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Omega-3 Fatty Acids Monotherapy in Children and Adolescents With Autism Spectrum Disorders

Conditions
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Autism Spectrum Disorder (ASD)

Intervention / Treatment
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* Drug: Omega-3 Fatty Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Male or female participants between 6 and 17 years of age, inclusive. Fulfills diagnosis of autism spectrum disorders by meeting DSM-IV-TR PDD diagnostic criteria of autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical interview assisted by MGH PDD Symptom Checklist. Participants with at least moderate symptom severity of ASD as reflected by SRS score ≥ 85 and CGI-PDD severity score of ≥ 4 (moderately ill). Subjects must be psychotropic drug-free for a minimum of four weeks prior to the baseline visit. Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria. Exclusion I.Q. < 85. DSM-IV-TR PDD diagnoses of Rett's disorder, and childhood disintegrative disorder. Current diagnosis of a psychotic disorder or unstable mood or anxiety disorders as determined by the clinician. Subject with marked severity of symptoms as suggested by the score of ≥ 5 (markedly ill) on CGI severity subscale for respective comorbid psychiatric disorders. Clinically unstable psychiatric condition judged to be at a serious risk to self or others as determined by the clinician. History of substance use (except nicotine or caffeine) within past 3 months, determined to be clinically significant by clinician. Urine drug screen positive for substances of abuse. Non-febrile seizures without a clear and resolved etiology in last month. Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including: Pregnant or nursing females; Organic brain disorders; Uncorrected hypothyroidism or hyperthyroidism, as determined by study clinician; Untreated and/or unstable diabetes; Subjects with a clinically significant abnormality according to cardiology consultation (ECGs with clinically concerning intervals including PR, QTC, QRS, will be reviewed by cardiology). History of renal or hepatic impairment determined to be clinically significant by clinician. Serious, unstable systemic illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease, as determined by clinician. Any other concomitant medication with primary central nervous system activity other than specified in the Concomitant Medication section of the protocol. Subjects who have difficulty swallowing pills. History of known allergy to Omega-3 fatty acids, multiple drug allergies, or severe allergies. A non-responder of, or history of intolerance to Omega-3 fatty acids, after treatment at an adequate dose and duration as determined by the clinician.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omega-3 Fatty Acid Treatment<br> | Drug: Omega-3 Fatty Acid<br>* Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.<br>* Other names: Fish Oil;|
| Placebo Comparator: Placebo (Sugar Pill)<br> | Drug: Omega-3 Fatty Acid<br>* Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.<br>* Other names: Fish Oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Social Responsiveness Scale (SRS) Total Raw Score | Change in SRS Total Raw Score | pre-treatment, 6 weeks, post-treatment (12 weeks) | 
| Change in NIMH Clinical Global Impression Scale for Pervasive Developmental Disorders (CGI-PDD) Improvement Scores | The CGI-PDD is a well-established, 3-item, clinician-rated measure of global symptom severity and treatment response, specifically for PDD. This scale allows the clinician to rate the severity of the participant's PDD relative to baseline. | weekly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omega-3 Fatty Acid, Autism Spectrum Disorders, Pervasive Developmental Disorders, Children, Cognitive Functioning