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

This study has been terminated.
(Due to a change in the research priorities of the principal investigator in combination with low subject interest.)
Sponsor:
Information provided by (Responsible Party):
Gagan Joshi, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01248130
First received: November 19, 2010
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Autism Spectrum Disorder (ASD)
Drug: Omega-3 Fatty Acid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Omega-3 Fatty Acids Monotherapy in Children and Adolescents With Autism Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in Social Responsiveness Scale (SRS) total raw score [ Time Frame: pre-treatment, 6 weeks, post-treatment (12 weeks) ] [ Designated as safety issue: No ]
  • Change in NIMH Clinical Global Impression Scale for Pervasive Developmental Disorders (CGI-PDD) improvement scores [ Time Frame: weekly ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: November 2009
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Fish Oil

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248130

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Gagan Joshi, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Gagan Joshi, MD, Clinical Investigator, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01248130     History of Changes
Other Study ID Numbers: 2009-P-001593
Study First Received: November 19, 2010
Last Updated: October 24, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Omega-3 Fatty Acid
Autism Spectrum Disorders
Pervasive Developmental Disorders
Children
Cognitive Functioning

Additional relevant MeSH terms:
Child Development Disorders, Pervasive
Autistic Disorder
Disease
Mental Disorders Diagnosed in Childhood
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014