Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Rutgers, The State University of New Jersey.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00467818
First received: April 27, 2007
Last updated: November 23, 2010
Last verified: November 2010
  Purpose

Published studies on omega 3 fatty acids in the treatment of bipolar disorder and schizophrenia have shown reductions in time to recurrence, a decrease in the positive and negative symptoms of schizophrenia, and improvements in CGI, YMRS, and HAM-D scores. The following are the hypotheses:

  • Omega 3 fatty acids will be superior to placebo in the acute treatment of global autism.
  • Omega 3 fatty acids will be superior to placebo in improving aggression and irritability associated with autism.
  • Omega 3 fatty acids will be superior to placebo in improving functional ability.

Condition Intervention
Autism
Dietary Supplement: Omega 3 fatty acids
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Clinical Global Impression-Improvement (CGI) [ Time Frame: Administered biweekly ] [ Designated as safety issue: No ]
  • Aberrant Behavior Checklist (ABC) [ Time Frame: Administered every 4 weeks ] [ Designated as safety issue: No ]
  • Vineland Adaptive Behavior Scale [ Time Frame: Administered during the baseline visit and on week 12 ( termination) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overt Aggression Scale-Modified [ Time Frame: Administered every 4 weeks ] [ Designated as safety issue: No ]
  • Parental Stress Index [ Time Frame: Administered during the baseline visit and on week 12 ( termination) ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2007
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omega 3 fatty Acids
Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study.
Dietary Supplement: Omega 3 fatty acids
The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.
Other Name: Docasahexanoic acid
Placebo Comparator: Placebo
The placebo will be dispensed to subjects in the control group
Other: Placebo
Smae dosage as that of omega 3 fatty acids

Detailed Description:

This study is an innovative treatment approach to autism. It adapts a promising adjunct therapy for bipolar disorder and schizophrenia to a new population, that of children and adolescents with autism. It will analyze the possible relationship between dosage of omega 3 fatty acids and treatment outcomes. Finally, it will attempt to identify which specific subgroups of subjects will respond to this intervention, which components and associated features are most responsive and whether this impacts subjects' quality of life. The data generated by this study is intended to support the rationale for a full scale, large multi-site clinical trial.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child/Teen has autism.
  • He/She is between five and seventeen years of age.
  • He/She is not in the hospital.
  • He/She has a parent or legal guardian who is willing and able to sign the informed consent.

Exclusion Criteria:

  • Child/Teen has been diagnosed with a psychotic disorder (such as schizophrenia) or a mood disorder, including depression or bipolar disorder (manic depression).
  • He/She has caused visible harm to him/herself or is at risk for suicide.
  • He/She has an active seizure disorder or epilepsy (seizures within the past year).
  • He/She has an unstable medical illness, including heart disease.
  • He/She has experienced brain injury.
  • He/She has a history of diabetes.
  • He/She has a history of prior treatment with Omega 3 Fatty Acids.
  • He/She lives in a far away area and/or does not have regular access to transportation to the clinical facility.
  • A pregnant female or unwilling to use acceptable contraception if sexually active.
  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: NCT00467818

Contacts
Contact: Rakhee Wasiulla, PhD 732-235-5690 wasiulra@umdnj.edu
Contact: Sherie Novotny, MD 732-235-4119 novotnsl@umdnj.edu

Locations
United States, New Jersey
University Behavioral Health Care Building, UMDNJ-RWJMS Recruiting
Piscataway, New Jersey, United States, 08854
Sub-Investigator: Susan Adubato, Ph.D         
Sub-Investigator: Kevin Chen, Ph.D         
Sub-Investigator: Rakhee Wasiulla, PhD         
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Sherie L. Novotny, MD Division of Child and Adolescent Psychiatry at the University of Medicine and Dentistry of New Jersey
  More Information

Additional Information:
Publications:
Amminger GP, Berger GE, Schafer MR, Klier C, Friedrich MH, Feucht M. Omega-3 Fatty Acids Supplementation in Children with Autism. Biol Psychiatry. 2006 Aug 22 Harel Z, Gascon G, Riggs S, Vaz R, Brown W, Exil G. Supplementation with omega-3 polyunsaturated fatty acids in the management of recurrent migraines in adolescents. J Adolesc Health. 2002 Aug;31(2):154-61. Itomura M, Hamazaki K, Sawazaki S, Kobayashi M, Terasawa K, Watanabe S, Hamazaki T. The effect of fish oil on physical aggression in schoolchildren. J Nutr Biochem. 2005 Mar;16(3):163-71. Mitchell EA, Aman MG, Turbott SH, Manku M. Clinical characteristics and serum essential fatty acid levels in hyperactive children. Clin Pediatr 1987; 26:406-11. Nemets H, Nemets B, Apter A, Bracha Z, Belmaker RH Omega-3 treatment of childhood depression: Am J Psychiatry. 2006 Jun;163(6):1098-100. Richardson AJ, Montgomery P. The Oxford-Durham study. Pediatrics. 2005 May;115(5):1360-6.

Responsible Party: Dr.Sherie Novotny, UMDNJ-RWJMS
ClinicalTrials.gov Identifier: NCT00467818     History of Changes
Other Study ID Numbers: 0220060238
Study First Received: April 27, 2007
Last Updated: November 23, 2010
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:
Aggression
Irritability
Global severity

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

ClinicalTrials.gov processed this record on August 01, 2014