Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders (NCT00467818) | Clinical Trial Compass
CompletedNot Applicable
Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders
United States17 participantsStarted 2007-01
Plain-language 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.
Who can participate
Age range
5 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Global Impression Scale(CGI)- Improvement
Timeframe: Administered biweekly, endpoint score (week 12) only used for data analysis
2
Aberrant Behavior Checklist (ABC)
Timeframe: Administered every 4 weeks, 12 week scores used for means, score on irritability subscale reported
3
Vineland Adaptive Behavior Scale
Timeframe: Administered during the baseline visit and on week 12 ( termination)
Trial details
NCT IDNCT00467818
SponsorUniversity of Medicine and Dentistry of New Jersey