Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders
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|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||Phase|
|Autism||Dietary Supplement: Omega 3 fatty acids Other: Placebo||Not Applicable|
|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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|