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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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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

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Autism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Omega 3 fatty Acids, drug

Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study.

Group Type ACTIVE_COMPARATOR

Omega 3 fatty acids

Intervention Type DRUG

The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.

Placebo

The placebo will be dispensed to subjects in the control group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Same dosage as that of omega 3 fatty acids

Interventions

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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.

Intervention Type DRUG

Placebo

Same dosage as that of omega 3 fatty acids

Intervention Type OTHER

Other Intervention Names

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DHA and EPA

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No