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

NCT00467818 | Completed Results DMC

• 2 other identifiers: 02200602385R21AT002927
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism

Keywords

Aggression; Irritability; Global severity

Outcome Measures

Primary Outcomes (3)

• Clinical Global Impression Scale(CGI)- Improvement

  This scale measures the impression of improvement as assessed from interviewing the subject and informant.The scale is measured with numbers from 0 through 7 with 0 not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. Units = scores on a scale.

  Administered biweekly, endpoint score (week 12) only used for data analysis

• Aberrant Behavior Checklist (ABC)

  Aberrant Behavior Checklist (ABC)-Community Version (Irritability Subscale) (Aman et al. 1985). It is designed to objectively identify five behavior subscales through observation by the primary caregiver. The five behavior subscales include (ranges show no problem to severe problem): irritability (range 0-45), lethargy (range 0-48), stereotypy (range 0-21), hyperactivity range 0-48), and inappropriate speech (range 0-12), all possible signs and symptoms of affective instability in autistic individuals (Lainhart \& Folstein, 1994). Improvement is shown with scores decreasing over time. Total score is not used. Inter-rater reliability for the ABC-CV is moderate to high across subscales with a mean of .63. Test-retest reliability correlations are .98 -Irritability, .99 -Lethargy, .98 -Stereotypy, .98 -Hyperactivity, and .96 -Inappropriate Speech. The ABC will be filled out by an informant (teacher/parent), and then reviewed by the IE. Administration time is approximately 10 minutes.

  Administered every 4 weeks, 12 week scores used for means, score on irritability subscale reported

• Vineland Adaptive Behavior Scale

  The Vineland Scale is a semi-structured informant interview that assesses subjects' functioning. It is administered to a caretaker/family member. The scale has been revised and standardized in all populations. This scale has been found to assess social deficits in autism and strengths in daily living skills. Items are classified under four major adaptive domains: communication, daily living skills, socialization and motor skills. The items are scored 0-2 (yes/sometimes/never). Each domain is summed, and the domain scores are converted to standardized scores. The normative score is 100, with standard deviation of 15. The standardized score is used in this study. A higher score (above 100) means better adaptive behavior. Minimum value is 0, maximum value is infinity.

  Administered during the baseline visit and on week 12 ( termination)

Secondary Outcomes (2)

• Overt Aggression Scale-Modified

  Administered biweekly and at week 12 (termination)

• Parental Stress Index

  Administered during the baseline visit and on week 12 ( termination)

Study Arms (2)

Omega 3 fatty Acids, drug

ACTIVE COMPARATOR

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

Drug: Omega 3 fatty acids

Placebo

PLACEBO COMPARATOR

The placebo will be dispensed to subjects in the control group

Other: Placebo

Interventions

Omega 3 fatty acids DRUG

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

Also known as: DHA and EPA

Omega 3 fatty Acids, drug

Placebo OTHER

Same dosage as that of omega 3 fatty acids

Placebo

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University Behavioral Health Care Building, UMDNJ-RWJMS

Piscataway, New Jersey, 08854, United States

Location

Related Publications (1)

• 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.

  RESULT

Related Links

• University Behavior Health Care official website

MeSH Terms

Conditions

Autistic Disorder; Aggression

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Limitations and Caveats

One subject had a recurrence of a psychiatric issue ( although might be unrelated to the intake of the placebo which he was on) which lead to hospitalisation and discontinuation of taking the placebo and subsequent withdrawal from the study.

Results Point of Contact

• Title: Sherie Novotny MD
• Organization: UMDNJ

novotnsl@rutgers.edu

(732) 235-4119

Study Officials

• Sherie L. Novotny, MD

  Division of Child and Adolescent Psychiatry at the University of Medicine and Dentistry of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Psychiatry, RWJMS

Study Record Dates

• First Submitted: April 27, 2007
• First Posted: May 1, 2007
• Study Start: January 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 26, 2021
• Results First Posted: December 16, 2020

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)