N/A
Completed N=17
Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders
Source: ClinicalTrials.gov NCT00467818 ↗Enrolled (actual)
17
Serious AEs
5.9%
Results posted
Dec 2020
Primary outcomePrimary: Clinical Global Impression Scale(CGI)- Improvement — 3.57; 3.8 units on a scale — p=1.0
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Global Impression Scale(CGI)- Improvement |
3.57; 3.8 | 1.0 |
| PRIMARY Aberrant Behavior Checklist (ABC) |
5.66; 8.5 | 0.10 |
| PRIMARY Vineland Adaptive Behavior Scale |
51.5; 27.5 | — |
| SECONDARY Overt Aggression Scale-Modified |
3.8; 2.4 | <0.5 |
| SECONDARY Parental Stress Index |
314.2; 279.5 | 0.5 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00467818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.