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

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.

Study Overview

• Status: Terminated
• Conditions: Autism Spectrum Disorder (ASD)
• Intervention / Treatment: Drug: Omega-3 Fatty Acid

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion

1. Male or female participants between 6 and 17 years of age, inclusive.
2. 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.
3. Participants with at least moderate symptom severity of ASD as reflected by SRS score ≥ 85 and CGI-PDD severity score of ≥ 4 (moderately ill).
4. Subjects must be psychotropic drug-free for a minimum of four weeks prior to the baseline visit.
5. 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

1. I.Q. < 85.
2. DSM-IV-TR PDD diagnoses of Rett's disorder, and childhood disintegrative disorder.
3. Current diagnosis of a psychotic disorder or unstable mood or anxiety disorders as determined by the clinician.
4. Subject with marked severity of symptoms as suggested by the score of ≥ 5 (markedly ill) on CGI severity subscale for respective comorbid psychiatric disorders.
5. Clinically unstable psychiatric condition judged to be at a serious risk to self or others as determined by the clinician.
6. History of substance use (except nicotine or caffeine) within past 3 months, determined to be clinically significant by clinician.
7. Urine drug screen positive for substances of abuse.
8. Non-febrile seizures without a clear and resolved etiology in last month.

9. Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including:

   1. Pregnant or nursing females;
   2. Organic brain disorders;
   3. Uncorrected hypothyroidism or hyperthyroidism, as determined by study clinician;
   4. Untreated and/or unstable diabetes;
   5. Subjects with a clinically significant abnormality according to cardiology consultation (ECGs with clinically concerning intervals including PR, QTC, QRS, will be reviewed by cardiology).
   6. History of renal or hepatic impairment determined to be clinically significant by clinician.
10. Serious, unstable systemic illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease, as determined by clinician.
11. Any other concomitant medication with primary central nervous system activity other than specified in the Concomitant Medication section of the protocol.
12. Subjects who have difficulty swallowing pills.
13. History of known allergy to Omega-3 fatty acids, multiple drug allergies, or severe allergies.
14. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Omega-3 Fatty Acid Treatment	Drug: Omega-3 Fatty Acid; 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.; Other Names: Fish Oil
Placebo Comparator: Placebo (Sugar Pill)	Drug: Omega-3 Fatty Acid; 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.; Other Names: Fish Oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Social Responsiveness Scale (SRS) Total Raw Score	The SRS is a 65-item rating scale completed by the participants parent or guardian. The scale measures the severity of autism spectrum symptoms as the occur in natural social settings. The total raw score is calculated by summing the 65 items. Total scores range from 0 to 195, where higher scores indicate greater severity. The outcome reported reflects the change from baseline (pre-treatment) in SRS Total raw score. When examining change from baseline, negative scores represent improvement (i.e., decrease in severity from baseline).	Pre-treatment - 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in NIMH Clinical Global Impression Scale for Pervasive Developmental Disorders (CGI-PDD) Improvement Scores	The CGI-PDD Improvement scale is a clinician-rated assessment of the participant's improvement in symptoms compared to baseline. The CGI-PDD-I is rated on a scale of one (very much improved) to seven (very much worse) and values of zero (not assessed) are assigned to all participants at baseline. The outcome reported reflects the change in improvement score from baseline, where lower scores indicate greater improvement compared to baseline.	Pre-treatment - 12 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Gagan Joshi, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: November 19, 2010
• First Submitted That Met QC Criteria: November 23, 2010
• First Posted (Estimated): November 25, 2010

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Children; Autism Spectrum Disorders; Omega-3 Fatty Acid; Pervasive Developmental Disorders; Cognitive Functioning
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autism Spectrum Disorder; Autistic Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: 2009-P-001593