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

Focus of Study:

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 dose of omega 3 fatty acids and treatment outcomes. Finally, it will attempt to identify which specific subgroup of subjects with autism will respond to this intervention, which components and associated features are most responsive and whether this impacts subjects’ quality of life.

Purpose:

1. To assess the effect of omega 3 fatty acids vs. placebo treatment on the global severity of child and adolescent autistic disorder, via a 12-week double blind placebo-controlled parallel study.

2. To assess the effect of omega 3 fatty acids vs. placebo treatment on symptoms of aggression and irritability associated with autism.

3. To assess the effect of omega 3 fatty acids vs. placebo treatment on functional ability.

Condition:

Double blind placebo controlled

Intervention:

Omega 3 fatty acid vs placebo

Study Type:

Pilot study

Study Design:

This is a 3 year study comparing omega 3 fatty acids and placebo as adjuncts in the treatment of autistic disorder. Sixty child or adolescent outpatients, with age ranges from 5-17, will be randomized into a 12-week double-blind, placebo-controlled parallel treatment study. During the 12 weeks, patients will be monitored and assessed by the treating psychiatrist. The psychiatrist will perform study assessments at designated time points while remaining blind to medication regimens.

Primary Outcome Measures:

Clinical Global Impression of improvement of autism symptoms

Aggression and Irritability

Functional Abililty

Secondary Outcome Measures:

Parental Stress Index

Enrollment:

Currently enrolling

Study Start Date:

10/19/2007

Groups:

Study group- on Omega 3 fatty acids

Control group- on placebo

Ages of Eligibility:

5-17years

Gender:

Male as well as Female

Inclusion Criteria:

1. Meets DSM-IV, ADI, and ADOS criteria for autistic disorder

2. Age 5-17.

3. Outpatients

4. Parent/legal guardian signing informed consent, and assent documented for patient with demonstrated capacity to provide it.

5. Sexually active females of childbearing potential must use an acceptable method of birth control (oral contraceptive medications [the administration of which must be supervised by a parent or guardian], IUD, depot medication, double barrier or tubal ligation) and have a negative serum pregnancy test prior to entry into the study.

6. Subject scores at least “4” (moderately ill) on the Clinical Global Impression-Severity Scale for Autistic Disorder (CGI-AD).

7. Subject meets the following criteria at pre-study diagnostic assessment and baseline assessment: ABC-Irritability Subscale ³ 18 (raw scores).

8. Subjects with history of seizures, who have been seizure-free for ³6 months on a stable dose of anticonvulsant medication. Non-medicated subjects with a history of seizures who have been seizure-free for ³6 months. Subjects with abnormal EEG but no clinical seizures.

Exclusion Criteria:

1. Subjects who are pregnant or nursing mothers. Sexually active females of childbearing potential who are not using adequate birth control measures (detailed above in inclusion criteria).

2. Subjects with overall adaptive behavior scores below the age of two years on the Vineland Adaptive Behavior Rating Scale.

3. Subjects with active or unstable epilepsy.

4. Subjects who are a Subjects with any of the following past or present mental disorders: schizophrenia, schizoaffective disorder, major depressive disorder, bipolar I or II disorders or substance abuse disorders.

5. serious suicidal risk.

6. Subjects with clinically significant or unstable medical illness that would contraindicate participation in the study, including hematopoietic or cardiovascular disease, pancreatitis, liver toxicity, and polycystic ovary syndrome.

7. Subjects reporting history of encephalitis, phenylketonuria, tuberous sclerosis, fragile X syndrome, anoxia during birth, pica, neurofibromatosis, hypomelanosis of Ito, hypothyroidism, Duchenne muscular dystrophy, and maternal rubella.

8. Patients with history of the following:

*gastrointestinal, liver, or kidney, or other known conditions which will presently interfere presently with the absorption, distribution, metabolism, or excretion of drugs.

*cerebrovascular disease or brain trauma

*clinically significant unstable endocrine disorder, such as hypo- or hyperthyroidism

*recent history or presence of any form of malignancy

9. Treatment within the previous 30 days with any drug known to a well-defined potential for toxicity to a major organ

10. Subjects with clinically significant abnormalities in laboratory tests or physical exam.

11. Subjects likely to require ECT.

12. Subjects unable to tolerate taper from psychoactive medication if necessary.

13. Subjects with a history of hypersensitivity or severe side effects associated with the use of divalproex sodium, or other an ineffective prior therapeutic trial of omega three fatty acids.

14. Subjects who have received any of the following interventions within the prescribed period before starting treatment:

* investigational drugs within the previous 30 days.

15. Subjects who have begun any new alternative non-medication treatments, such as diet, vitamins, and psychosocial therapy, within the previous three months.

16. Subjects with any organic or systemic disease or patients who require a therapeutic intervention, not otherwise specified, which would confound the evaluation of the safety of the study medication.

17. Subjects who reside in a remote geographical area who do not have regular access to transportation to the clinical facility.

Contacts:

PI: Dr.Sherie Novotny

novotnsl@umdnj.edu

Study Co ordinator: Rakhee Wasiulla

wasiulra@umdnj.edu

Locations:

University Behavioral Health Care ( UBHC), UMDNJ-RWJMS, Piscataway, NJ- 08854

Sponsors & Collaborators:

National Center for Complimentary and Alternative Medicine (NCCAM)

Investigators:

Principial Investigator: Dr.Sherie Novotny