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Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders - NCT00467818-08854(Clinical Trial 169207)



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City:  Piscataway
State:  
NJ
Zip Code: 08854
Conditions: Autism
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.
Study summary: 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.
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.
Study is available at: University Behavioral Health Care Building, UMDNJ-RWJMS
Piscataway, NJ 08854
United States

Primary Contact:
Rakhee Wasiulla, PhD
Email: wasiulra@umdnj.edu
Phone: 732-235-5690
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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