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 University of Medicine and Dentistry New Jersey.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Medicine and Dentistry New Jersey
Collaborator:
Information provided by:
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00467818
First received: April 27, 2007
Last updated: November 23, 2010
Last verified: November 2010
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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:
MedlinePlus related topics:
Autism
Drug Information available for:
Omega-3 Fatty Acids
U.S. FDA Resources
Further study details as provided by University of Medicine and Dentistry 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
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 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 University of Medicine and Dentistry 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 May 19, 2013