AutismNCT00467818

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

A study testing Omega 3 fatty acids in people with Autism, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 5 to 17 years
Conditions the study is for: Autism
What is being tested?: Omega 3 fatty acids
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 17 participants
Where: 1 siteUnited States
Study dates: Jan 2007to Dec 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University Behavioral Health Care Building, UMDNJ-RWJMS
Piscataway, New Jersey, 08854

Other trials in United States

About this study

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.

Read the 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.

Conditions: Autism
Being tested: Omega 3 fatty acids, Placebo
Keywords: Aggression, Irritability, Global severity
Medical subject headings: Autistic Disorder, Aggression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Omega 3 fatty acidsDrug
Also called DHA and EPA
The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.
PlaceboOther
Same dosage as that of omega 3 fatty acids

Study groups in NCT00467818
Study group	Role	What they receive
Omega 3 fatty Acids, drug	Active comparator	Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study. Receives: Drug: Omega 3 fatty acids
Placebo	Placebo comparator	The placebo will be dispensed to subjects in the control group Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Overt Aggression Scale-Modified
The Modified version, Coccaro et al. is designed for outpatient use and assessment of behavior over one week. This scale was assessed biweekly. The OAS-M consists of 3 domains: Aggression, Irritability, and Suicidality (not used). Aggression Domain: 4 subscales of weighted behavior: Verbal Aggression (1), Aggression Against Objects (2), Aggression Against Others (3), and Self-Aggression (4). Within each category, severity of an event receives a scaled score (0-5) (higher score for worse behaviors) which is then multiplied by the weekly frequency of this event and weight, then totaled (for use in this study). Irritability subscale is divided into subjective/objective, 0 (low)-5 (high). The total scale has a minimum value of 0 (no display of aggressive/irritable behavior) and a maximum value of infinity (worse aggressive/irritable behavior) as reporting the number of times an aggressive/irritable behavior occurred does not have a maximum value). Higher scores mean worse outcome.
Measured: Administered biweekly and at week 12 (termination)
Parental Stress Index
This measurement assesses child and parental characteristics and parent-child relationship dimensions associated with the presence of parenting stress/ troubled relationships. It is a self-report scale completed by the parent, consisting of 101 items organized into two domains with the following subscales: (1) child characteristics domain - adaptability, demandingness, mood, distractibility/hyperactivity, acceptability of child to parent, and child's reinforcement of parent, and (2) parent characteristics domain - depression, attachment to child, social isolation, sense of competence in the parenting role, relationship with spouse/parenting partner, role restrictions, and parental health. Scores are 1-5 with 1 being strongly agree and 5 being strongly disagree. Scores are collected and standardized. The higher a score is, the more stress a parent is experiencing. Minimum value is 101 and maximum value is 505.
Measured: Administered during the baseline visit and on week 12 ( termination)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Dec 2010

First posted1 May 2007 (estimated)
Study startJan 2007
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AutismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00467818
Sponsor's protocol ID: 0220060238
Other IDs: 5R21AT002927
Status last verified: Jan 2021
First submitted: 27 Apr 2007
Last updated: 26 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: There is no plan at this time.

Publications

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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders
ClinicalTrials.gov ID: NCT00467818
Acronym / sponsor ID: 0220060238
Conditions: Autism
Keywords: Aggression, Irritability, Global severity
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: University of Medicine and Dentistry of New JerseyUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: Jan 2007
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 1 May 2007 (estimated)
Results: Posted 16 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Omega 3 fatty Acids, drug	Active comparator	Drug: Omega 3 fatty acidsOmega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study.
Placebo	Placebo comparator	Other: PlaceboThe placebo will be dispensed to subjects in the control group

Who may qualify

Ages: 5 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Omega 3 fatty acidsAlso: DHA and EPAThe study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.	Drug	Omega 3 fatty Acids, drug
PlaceboSame dosage as that of omega 3 fatty acids	Other	Placebo

Primary outcome

Clinical Global Impression Scale(CGI)- Improvement
Time frame: Administered biweekly, endpoint score (week 12) only used for data analysis
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.
Aberrant Behavior Checklist (ABC)
Time frame: Administered every 4 weeks, 12 week scores used for means, score on irritability subscale reported
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.
Vineland Adaptive Behavior Scale
Time frame: Administered during the baseline visit and on week 12 ( termination)
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.

2 secondary outcomes

Overt Aggression Scale-Modified
Time frame: Administered biweekly and at week 12 (termination)
Parental Stress Index
Time frame: Administered during the baseline visit and on week 12 ( termination)

Results and safety

Results posted to the registry on 16 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Omega 3 Fatty Acids, Drug	9	6
Placebo	8	6

Primary outcome: Clinical Global Impression Scale(CGI)- Improvement

Time frame: Administered biweekly, endpoint score (week 12) only used for data analysis. Mean (Standard Deviation). Unit: units on a scale

Measure	Omega 3 Fatty Acids, Drug n = 6	Placebo n = 6
Value	3.57 (1.2)	3.8 (1.2)

Omega 3 Fatty Acids, Drug vs Placebo: p = 1.0, t-test, 2 sided

Primary outcome: Aberrant Behavior Checklist (ABC)

Time frame: Administered every 4 weeks, 12 week scores used for means, score on irritability subscale reported. Mean (Standard Deviation). Unit: units on a scale

Measure	Omega 3 Fatty Acids, Drug n = 6	Placebo n = 6
Value	5.66 (5.0)	8.5 (2.1)

Omega 3 Fatty Acids, Drug vs Placebo: Mean Difference (Final Values): 0.10, p = 0.10, Mixed Models Analysis

Population analysed: Youth and adolescents ages 5-17 with autism spectrum disorder

Primary outcome: Vineland Adaptive Behavior Scale

Time frame: Administered during the baseline visit and on week 12 ( termination). Mean (Standard Deviation). Unit: units on a scale

Measure	Omega 3 Fatty Acids, Drug n = 6	Placebo n = 6
Value	51.5 (13.28)	27.5 (9.81)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse event data were collected over the course of the study from the start in 2007 until completion in 2011. Each participant was observed for adverse events during the course of their treatment which was the course of the study, ie 12 weeks. Participants were not monitored for adverse events after the completion of the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Omega 3 Fatty Acids, Drug	0 of 9 (0%)	0 of 9 (0%)	Not reported
Placebo	1 of 8 (12.5%)	0 of 8 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationAmminger 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.
University Behavior Health Care official websiteLink provided by the sponsor.
Individual participant dataSharing planned: No. There is no plan at this time.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sherie L. Novotny, MD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Omega 3 fatty acids in people with Autism, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Global Impression Scale(CGI)- Improvement (time frame: Administered biweekly, endpoint score (week 12) only used for data analysis). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00467818, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.