Clinical trial NCT00467818: Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders
Official title: Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Keywords: Aggression
Irritability
Global severity
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2007-05-01
Enrollment: 17
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Clinical Global Impression Scale(CGI)- Improvement
timeFrame: Administered biweekly, endpoint score (week 12) only used for data analysis
measure: Aberrant Behavior Checklist (ABC)
timeFrame: Administered every 4 weeks, 12 week scores used for means, score on irritability subscale reported
measure: Vineland Adaptive Behavior Scale
timeFrame: Administered during the baseline visit and on week 12 ( termination)
Secondary outcomes:
measure: Overt Aggression Scale-Modified
timeFrame: Administered biweekly and at week 12 (termination)
measure: Parental Stress Index
timeFrame: Administered during the baseline visit and on week 12 ( termination)
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: University Behavioral Health Care Building, UMDNJ-RWJMS
state: New Jersey
Study officials:
affiliation: Division of Child and Adolescent Psychiatry at the University of Medicine and Dentistry of New Jersey
name: Sherie L. Novotny, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amminger GP, Berger GE, Schafer MR, Klier C, Friedrich MH, Feucht M. Omega-3 Fatty Acids Supplementation in Children with Autism. Biol Psychiatry. 2006 Aug 22 Harel Z, Gascon G, Riggs S, Vaz R, Brown W, Exil G. Supplementation with omega-3 polyunsaturated fatty acids in the management of recurrent migraines in adolescents. J Adolesc Health. 2002 Aug;31(2):154-61. Itomura M, Hamazaki K, Sawazaki S, Kobayashi M, Terasawa K, Watanabe S, Hamazaki T. The effect of fish oil on physical aggression in schoolchildren. J Nutr Biochem. 2005 Mar;16(3):163-71. Mitchell EA, Aman MG, Turbott SH, Manku M. Clinical characteristics and serum essential fatty acid levels in hyperactive children. Clin Pediatr 1987; 26:406-11. Nemets H, Nemets B, Apter A, Bracha Z, Belmaker RH Omega-3 treatment of childhood depression: Am J Psychiatry. 2006 Jun;163(6):1098-100. Richardson AJ, Montgomery P. The Oxford-Durham study. Pediatrics. 2005 May;115(5):1360-6.