NCT00467818

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Medicine and Dentistry of New Jersey · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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 Clinical Global Impression Scale, Young Mania Rating Scale, 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.

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.

Conditions

• Autism

Interventions

Type	Name	Description
DRUG	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	Placebo	Same dosage as that of omega 3 fatty acids

Timeline

• Start date: 2007-01-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2007-05-01
• Last updated: 2021-01-26
• Results posted: 2020-12-16

Locations

1 site across 1 country: United States