Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT00467818
Status:
COMPLETED
Last Update Posted:
2021-01-26
First Post:
2007-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Study Overview
Official Title:
Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5R21AT002927 | NIH | None | https://reporter.nih.gov/quic… | View |