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

NCT01248130 | Terminated Phase 2 Results

• 1 other identifier: 2009-P-001593
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder (ASD)

Keywords

Omega-3 Fatty Acid; Autism Spectrum Disorders; Pervasive Developmental Disorders; Children; Cognitive Functioning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in NIMH Clinical Global Impression Scale for Pervasive Developmental Disorders (CGI-PDD) Improvement Scores

  Pre-treatment - 12 weeks

Study Arms (2)

Omega-3 Fatty Acid Treatment

ACTIVE COMPARATOR

Drug: Omega-3 Fatty Acid

Placebo (Sugar Pill)

PLACEBO COMPARATOR

Drug: Omega-3 Fatty Acid

Interventions

Omega-3 Fatty Acid DRUG

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.

Also known as: Fish Oil

Omega-3 Fatty Acid Treatment; Placebo (Sugar Pill)

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Child Development Disorders, Pervasive

Interventions

Fatty Acids, Omega-3; Fish Oils

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils

Limitations and Caveats

This study was terminated early due to a change in the research priorities of the Principal Investigator in combination with low subject interest. Therefore, no data was analyzed.

Results Point of Contact

• Title: Gagan Joshi, MD
• Organization: Massachusetts General Hospital

lkfeinberg@mgh.harvard.edu

617-726-4651

Study Officials

• Gagan Joshi, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD

Study Record Dates

• First Submitted: November 19, 2010
• First Posted: November 25, 2010
• Study Start: November 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: March 27, 2025
• Results First Posted: September 22, 2014

Record last verified: 2025-03

Locations

US (1)