Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders
Recruitment status was Recruiting
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 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|
- 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 ]
- 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 ]
|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)|
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
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.
|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|