Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders
|ClinicalTrials.gov Identifier: NCT00467818|
Recruitment Status : Unknown
Verified November 2010 by Rutgers, The State University of New Jersey.
Recruitment status was: Recruiting
First Posted : May 1, 2007
Last Update Posted : November 24, 2010
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 or disease||Intervention/treatment|
|Autism||Dietary Supplement: Omega 3 fatty acids Other: Placebo|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||September 2010|
|Estimated Study Completion Date :||September 2010|
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
Smae dosage as that of omega 3 fatty acids
- Clinical Global Impression-Improvement (CGI) [ Time Frame: Administered biweekly ]
- Aberrant Behavior Checklist (ABC) [ Time Frame: Administered every 4 weeks ]
- Vineland Adaptive Behavior Scale [ Time Frame: Administered during the baseline visit and on week 12 ( termination) ]
- Overt Aggression Scale-Modified [ Time Frame: Administered every 4 weeks ]
- Parental Stress Index [ Time Frame: Administered during the baseline visit and on week 12 ( termination) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00467818
|Contact: Rakhee Wasiulla, PhDfirstname.lastname@example.org|
|Contact: Sherie Novotny, MDemail@example.com|
|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|
|Principal Investigator:||Sherie L. Novotny, MD||Division of Child and Adolescent Psychiatry at the University of Medicine and Dentistry of New Jersey|